55 Qa Manager jobs in Mississauga
QA/QC Manager

Posted 5 days ago
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**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
AECOM is seeking a **QA/QC Manager** to join our team. This position is based on-site, out of Mississauga. We are seeking professionals to join our team to help us build one of the most advanced, sustainable and passenger-friendly airports in the world.
**Major Requirements:**
* Oversees the management of the monitoring and evaluation process to ensure that AECOM quality management systems are being followed and evidence is recorded and maintained.
* Provides guidance to employees within the latitude of established policies.
* Recommends changes to policies and establishes procedures that affect immediate organization.
* Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including understanding of current business trends.
* Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
* May have budget responsibilities.
* Manages the coordination of activities of a group or department with responsibility for results.
* In some instances, may be responsible for functional area and may not have direct reports.
**Qualifications**
**Minimum Requirements:**
BS plus 8 years of demonstrated equivalency of experience and/or education
+ Demonstrable expertise in quality control and quality assurance practices.
+ Demonstrated experience in managing teams to deliver quality management on complex projects and programs.
+ Experience throughout all project phases, including design, planning, construction, operations, and maintenance preferably large program/projects.
+ Good stakeholder engagement and communication skills including the ability to facilitate meeting / workshops with large groups of stakeholders.
+ Recognized degree and professional designation is considered an asset.
Certified QMS 2015 auditor or experience in a similar quality management representative role for a large program and successful completion of an ISO 9001 Lead Auditor Course.
**Preferred Requirements:**
+ Typically, 15 years of professional experience in a quality management position with at least 7 years in a management position.
+ 7 years professional experience in an international airport program or equivalent complex infrastructure program.
**Additional Information**
This position requires work on-site/out of the office 5 days a week.
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2024. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.
**ReqID:** J
**Business Line:** Transportation
**Business Group:** DCS
**Strategic Business Unit:** Canada
**Career Area:** Quality
**Work Location Model:** On-Site
**Legal Entity:** AECOM Canada ULC
Technical Lead - QA E2E Test Management
Posted 5 days ago
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Group Risk Specialist, Non-Model Risk Management - QA/QC (2855)
Posted 12 days ago
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Job Description
Toronto, Ontario, Canada
**Hours:**
37.5
**Line of Business:**
Risk Management
**Pay Details:**
$91,200 - $136,800 CAD
TD is committed to providing fair and equitable compensation opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The base pay actually offered may vary based upon the candidate's skills and experience, job-related knowledge, geographic location, and other specific business and organizational needs.
As a candidate, you are encouraged to ask compensation related questions and have an open dialogue with your recruiter who can provide you more specific details for this role.
**Job Description:**
**Job Description**
The Group Risk Specialist provides a comprehensive and diverse range of risk management expertise to business leaders. Leads and supports the implementation of appropriate risk frameworks and related management activities to mitigate enterprise and/or business-wide risk exposures for key business segment of the Bank or functional area. May provide oversight, commentary, and recommendations based on overall strategy and industry best practices.
The Non-Model/End-User-Computing Tool (EUC) Risk Management - QA/QC role provides second line of defense risk management and oversight of Non-Models/EUCs, which are analytical/computational tools that are used to support business processes and are not considered models. The role will support the governance of Non-Model/EUC risk to the bank by executing compliance and control testing to validate that Non-Models/EUC risks are managed in compliant with the bank's Non-Model Risk Management program.
**Depth & Scope:**
+ Highly seasoned professional role requiring substantial knowledge/expertise in a complex field and knowledge of broader related areas
+ Integrates knowledge of the enterprise sub-function's or business line's overarching strategy in developing solutions across multiple functions or operations
+ Interprets internal/external business challenges and the industry environment, recommends course of action and best practices to improve products, processes, or services
+ Acts as a technical expert/lead integrating cross-function understanding within their own field of specialty; may manage team(s) of related specialists
+ Leads cross-functional teams or projects with significant resource requirements, risk and/or complexity
+ Independently manages end-to-end functional programs
+ Solves or may lead others to solve complex problems; leads efforts or partners with others to develop new solutions
+ Uses sophisticated analytical thought to exercise judgement and identify solutions
+ Impacts the achievement of sub-function or business line objectives within the area they are accountable for
+ Work is guided by policies and industry standards/methods
+ Communicates difficult concepts; converts information to compelling business context and advice; influences and gains alignment across increasingly senior stakeholders
+ Works autonomously as the lead and guides others within area of expertise
**Education & Experience:**
+ Undergraduate degree or technical certificate and/or
+ 7+ years relevant experience
+ Advanced knowledge of risk management governance, programs, policies, practices, operating frameworks & reporting for business supported and/or area of discipline
+ Knowledge of risk management environment, standards, regulations, and mitigation
+ Knowledge of current and emerging competitor and market trends
+ Ability to establish goals and objectives which support the strategic plan
+ Ability to lead, plan, implement, and evaluate program/project activities to ensure completion of initiatives
+ Skill in mentoring and coaching
+ Advanced skill in using analytical software tools, data analysis methods and reporting techniques
+ Skill in using computer applications including MS Office
+ Ability to communicate effectively in both oral and written form
+ Ability to work collaboratively and build relationships across teams and functions
+ Ability to work successfully as a member of a team and independently
+ Ability to exercise sound judgement in making decisions
+ Ability to analyze, organize and prioritize work while meeting multiple deadlines
+ Ability to handle confidential information with discretion
**Preferred Qualifications**
+ Non-Model/EUC risk management/governance experience
+ Knowledge of Non-Model/EUC governance, risk, and compliance
+ Knowledge of Non-Model/EUC risk management framework, including risk level assessment and controls
+ Compliance or QA/QC testing or audit experience
+ Working knowledge or familiarity with desktop or web-based applications such as Excel, VBA, SQL, SAS, Access, Alteryx, Power BI, Python, and Tableau
**Customer Accountabilities:**
+ Leads the development and/or implementation of specific standards, policies and/or processes that identify, report on, and mitigate operational (or all major) risk exposures within the business
+ Proactively analyzes potential risks and ensures escalation of key risks to appropriate areas and/or executive review with business executive findings and action plans to mitigate and manage these risks
+ Establishes and provides on-going analysis and reporting on operational risk and/or other major risk categories as applicable to own business or functional area, and reviews findings and action plans with business leaders to mitigate and manage key issues
+ Coordinates and/or guides activities relating to core operational risk disciplines/programs including, Risk & Control Self-Assessment, Business Continuity Management, Outsourcing & Vendor Management, Regulatory Compliance (e.g., CDIC, AML, Privacy, IDA, CBA, SOX, Basel etc.)
+ Supports enterprise-wide operational risk escalation, review and approval processes, data management, policies, and risk assessment processes
+ Directs the development and monitoring of Key Risk Indicators and facilitate communication and resolution of risk issues among other business segments where applicable
+ May be accountable for managing ancillary operational risk areas (e.g., BCM/incident management, outsourcing/vendor management, fraud aggregation and assessment, Basel implementation/capital analysis, change management, Privacy, AML, LCM, and other regulatory issues), in addition to core functions
+ May be responsible for providing support for other major risk areas (e.g., Market, Credit, Reputational and/or Regulatory risks etc.)
+ May be a point of contact for guidance in the monitoring/reporting of compliance, management, and strategic initiatives
+ Provides broad/deep commentary in support of the development/maintenance/oversight of policies/procedures/practices, as required
**Shareholder Accountabilities:**
+ Adheres to enterprise frameworks or methodologies that relate to activities for our business area
+ Ensures respective programs/policies/practices are well managed, meet business needs, comply with internal and external requirements, and align with business priorities
+ Consistently exercises discretion in managing correspondence, information, and all matters of confidentiality; escalates issues where appropriate
+ Ensures business operations are in compliance with applicable internal and external requirements (e.g., financial controls, segregation of duties, transaction approvals and physical control of assets)
+ Participates in cross-functional/enterprise/initiatives as a subject matter expert helping to identify risk/provide guidance for complex situations
+ Conducts internal and external research projects; supports the development/delivery of presentations/communications to management or broader audience
+ Conducts meaningful analysis at the functional or enterprise level using results to draw conclusions, make recommendations and assess the effectiveness of programs/policies/practices
+ Monitors service, productivity and assesses efficiency levels within own function and implements continuous process/performance improvements where opportunities exist
+ Leads/facilitates and/or implements actions/remediation plans to address performance/risk/governance issues
+ Actively manages relationships within and across various business lines, corporate and/or oversight functions and ensures alignment with enterprise and/or regulatory requirements
+ Keeps abreast of emerging issues, trends, and evolving regulatory requirements and assesses potential impacts
+ Maintains a culture of risk management and control, supported by effective processes in alignment with risk appetite
**Employee/Team Accountabilities:**
+ Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation, and teamwork and ensures timely communication of issues/points of interest
+ Provides thought leadership and/or industry knowledge for own area of expertise in own area and participates in knowledge transfer within the team and business unit
+ Keeps current on emerging trends/developments and grows knowledge of the business, related tools, and techniques
+ Participates in personal performance management and development activities, including cross training within own team
+ Keeps others informed and up to date about the status/progress of projects and/or all relevant or useful information related to day-to-day activities
+ Contributes to team development of skills and capabilities through mentorship of others, by sharing knowledge and experiences and leveraging best practices
+ Leads, motivates, and develops relationships with internal and external business partners/stakeholders to develop productive working relationships
+ Contributes to a fair, positive, and equitable environment that supports a diverse workforce
+ Acts as a brand ambassador for your business area/function and the bank, both internally and/or externally
#LI-CorporateB
**Who We Are:**
TD is one of the world's leading global financial institutions and is the fifth largest bank in North America by branches/stores. Every day, we deliver legendary customer experiences to over 27 million households and businesses in Canada, the United States and around the world. More than 95,000 TD colleagues bring their skills, talent, and creativity to the Bank, those we serve, and the economies we support. We are guided by our vision to Be the Better Bank and our purpose to enrich the lives of our customers, communities and colleagues.
TD is deeply committed to being a leader in customer experience, that is why we believe that all colleagues, no matter where they work, are customer facing. As we build our business and deliver on our strategy, we are innovating to enhance the customer experience and build capabilities to shape the future of banking. Whether you've got years of banking experience or are just starting your career in financial services, we can help you realize your potential. Through regular leadership and development conversations to mentorship and training programs, we're here to support you towards your goals. As an organization, we keep growing - and so will you.
**Our Total Rewards Package**
Our Total Rewards package reflects the investments we make in our colleagues to help them and their families achieve their financial, physical, and mental well-being goals. Total Rewards at TD includes a base salary, variable compensation, and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off, banking benefits and discounts, career development, and reward and recognition programs. Learn more ( Information:**
We're delighted that you're considering building a career with TD. Through regular development conversations, training programs, and a competitive benefits plan, we're committed to providing the support our colleagues need to thrive both at work and at home.
Please be advised that this job opportunity is subject to provincial regulation for employment purposes. It is imperative to acknowledge that each province or territory within the jurisdiction of Canada may have its own set of regulations, requirements.
**Colleague Development**
If you're interested in a specific career path or are looking to build certain skills, we want to help you succeed. You'll have regular career, development, and performance conversations with your manager, as well as access to an online learning platform and a variety of mentoring programs to help you unlock future opportunities. Whether you have a passion for helping customers and want to expand your experience, or you want to coach and inspire your colleagues, there are many different career paths within our organization at TD - and we're committed to helping you identify opportunities that support your goals.
**Training & Onboarding**
We will provide training and onboarding sessions to ensure that you've got everything you need to succeed in your new role.
**Interview Process**
We'll reach out to candidates of interest to schedule an interview. We do our best to communicate outcomes to all applicants by email or phone call.
**Accommodation**
Your accessibility is important to us. Please let us know if you'd like accommodations (including accessible meeting rooms, captioning for virtual interviews, etc.) to help us remove barriers so that you can participate throughout the interview process.
We look forward to hearing from you!
**Language Requirement (Quebec only):**
Sans Objet
Federal law prohibits job discrimination based on race, color, sex, sexual orientation, gender identity, national origin, religion, age, equal pay, disability and genetic information.
Specialist, Quality Assurance
Posted 1 day ago
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**Position Title:** Specialist, Quality Assurance
**Department:** Quality DCV & GEM
**Location:** Toronto, ON
**About the Job**
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Contribute to establishing and maintaining high quality and compliance status of all products handled by Sanofi Canada to meet all Canadian cGMP regulations, as well as corporate requirements.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
+ Coordinates with QA Coordination Call Center to obtain essential information required to document technical complaints
+ Provides support to QA Coordination Call Center to meet needs of the complainant
+ Identifies and confirms inquiries as product technical complaints
+ Evaluates complaints for severity and risk to public safety.
+ Notifies interested departments (eg. Country Quality Head, manufacturing site QA,) upon receipt of critical complaints.
+ Monitors and tracks sample receipt from complaints.
+ Ensures complaints are reviewed and processed within a timely fashion
+ Prioritizes complaints for data entry and processing into the global database
+ Utilizes the customer service database to oversee complaint identification and processing
+ Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations
+ Performs QC Checks
+ Understands Health Canada complaint regulations for drug products and medical devices
+ Performs file review and administrative closure for individual complaints
+ Produces trending reports
+ Monitors open complaint activity for each manufacturing site
+ Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints
+ Identifies and reports adverse events within one business day to Pharmacovigilance
+ Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management
+ Participates on ad-hoc teams regarding product-specific complaint issues
+ Supports during regulatory, third party, and internal audits
+ Understands product specific information regarding common product complaints
+ Understands department process flows and complaint databases
+ Coordinates feedback to customers regarding complaint investigations via QA Coordination Call Center
+ Other QA duties, as assigned
**About You**
**Requirements & Qualifications**
+ B.Sc. in Chemistry, Biology or related sciences
+ 5 years of related experience within the pharmaceutical industry.
+ Knowledge of cGMPs and Health Canada regulations regarding drugs, medical devices, combination products, biologics and natural health products
+ Strong understanding of Good Documentation Practices
+ Must be able to understand and utilize complaint database software and reporting tools
+ SAP, MS Office, Adobe Suite
+ Bilingual French strongly preferred
+ Occasional travel: Position is based out of the Toronto office
+ *Persons applying for positions in QA must provide evidence of qualifications, as outlined in current Canadian Good Manufacturing Practices (GMP) Guidelines for review and assessment as a condition of any offers of employment.
**Preferred skills:**
+ Problem Solving mindset who is self-motivated, well organized with attention to detail and strong analytical skills.
+ Customer Service Skills, Project and Time Management Skills
+ Interpersonal skills-must be proactive, personable, flexible, team-oriented
+ Ability to multitask in a stressful environment and to operate in a constantly changing environment
+ Strong Verbal and Written Communication Skills
_*Persons applying for positions in QA must provide evidence of qualifications, as outlined in current Canadian Good Manufacturing Practices (GMP) Guidelines for review and assessment as a condition of any offers of employment._
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
This position is for a current vacant role that we are actively hiring for.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
#GD-SG
#LI-GZ
#LI-Onsite
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
_North America Applicants Only_
The salary range for this position is:
$76,200.00 - $10,066.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK ( .
La fourchette salariale pour ce poste est la suivante:
76,200.00 - 110,066.66
Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le lien ( .
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
Quality Assurance Associate
Posted 2 days ago
Job Viewed
Job Description
Staff Management | SMX is immediately hiring a Quality Assurance Associate for our food manufacturing Client in Brampton. This is a full time, 2-month contract position.
.
Perks & Benefits: Weekly paychecks.
Shifts: 2nd Shift, 3rd Shift.
Employment Types: Full Time.
Pay Rate: $18.00 - $9.00 / hour
Duties:
+ Conduct routine line checks including temperature, metal detector verification, weights, pouch integrity, and analytical tests (e.g., brix, pH, viscosity, water activity).
+ Monitor Critical Control Points (CCPs) and chart recorders.
+ Record results on controlled documents accurately.
+ Investigate and report on non-conformances to maintain quality standards.
+ Collect various samples for testing.
.
Position Requirements:
+ University degree or college diploma in Science (with Concentration in Chemistry, Biochemistry, or Microbiology) or Food Science.
+ Food industry experience considered a strong asset.
+ Strong ability to work independently, multitask effectively in a fast paced environment.
+ Strong numeracy, written and verbal communication skills.
Requirements: Stand for Shift Duration, Must be at least 18 years old., required education: HS Diploma or GED.
Work Location: Staff Management, Brampton, ON L6S6B7.
Job Types: Food Production, Manufacturing, Production, Warehouse, Quality.
Industry: Manufacturing.
The hourly rate for this position is anticipated between 18.00 - 19.00 per hour. This range is a good-faith estimate, based on the shift you work and other considerations permitted by law. An employee''s pay history will not be a contributing factor where prohibited by local law.
TBI Outsourcing Canada, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, sexual orientation, age, gender identification, protected veteran status, or any other characteristic protected by law. We consider qualified applicants with arrest and conviction records in accordance with applicable law.
Accommodations are available on request for candidates taking part in the selection process. If you require disability-related accommodation during the recruitment process, please contact your Recruiter or Employee Relations at or . TrueBlue, Inc. and its brands will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.
SM | SMX is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, sexual orientation, age, gender identification, protected veteran status, or any other characteristic protected by law.
Quality Assurance Specialist
Posted 2 days ago
Job Viewed
Job Description
**The Position**
**A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.**
**That's what makes us Roche.**
At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. We serve our patients through external partnerships because access to quality products is every patient's right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.
**The Opportunity:**
+ Provide quality and compliance oversight of external GMP suppliers including CDMOs, CROs/PET centers, CLOs and in-licensing partners to ensure compliance with cGMP and quality agreement requirements.
+ Serve as the Quality Point of Contact for these GMP suppliers and participate as a key member of cross-functional management teams to enable GMP supplier site selection, qualification and implementation, management, and decommissioning
+ Oversee and execute all required quality activities during the lifecycle of a GMP supplier, including but not limited to:
+ Negotiation and maintenance of Quality Agreements and associated documents
+ Monitoring cGMP compliance and reporting quality performance, identifying and mitigating quality risks
+ Supporting Roche audits, ensuring audit responsiveness and CAPA implementation
+ Tech transfers and process validation, and Inspection readiness for commercial CMOs as applicable
***
+ Execute all required activities to support Make Assess and Release commercial and investigational medicinal products, including but not limited to risk assessments, approval of method validation, master batch records and executed records, complex investigations, and changes. Ensure project milestones as well as expectations such as on time closure are met.
+ Serve as Quality Point of Contact to the technical development team, and provide end-to-end quality oversight. Execute the Product Specification File (PSF), intra-company agreements, approve the control system, review CMC sections of Health Authority submissions and related activities.
+ Perform disposition of outsourced investigational medicinal products in SAP, including API and Drug Product of Synthetic Molecules and Biologics
**Who you are:**
+ B.S., M.Sc. or PhD in life sciences or equivalent with at least 8 years Manufacturing and/or Quality experience with Synthetic Molecules including Steriles in the pharmaceutical or related GMP industry. Experience with siRNA (oligos/peptides) and Biologics is a plus.
+ The ideal candidate has GMP QA experience of bulk API and Drug Product clinical supply operations including release.
+ Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GMP products.
+ Excellent Quality decision making skills in complex environments
+ Proven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiatives
+ Ability to operate in a self-managed way of working, with a key focus on collaboration, agility and innovation mindset
+ Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness
**This position may require up to 10% domestic and/or international travel**
*** Relocation benefits not available for this position***
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
**Roche is an Equal Opportunity Employer.**
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