Vice President Quality Medical Device jobs
- TevaWhitchurch-Stouffville, ON
- Serve as the highest-ranking quality authority on site with independent decision-making responsibility regarding product quality and potential market actions.
View similar jobs with this employerCapgeminiBurlington, ON- Permanent
- 10+ years of experience in software quality assurance within regulated environments (medical device preferred).
- Thermo Fisher ScientificMississauga, ON
- $133,600–$178,100 a year
- Full-time
- Monday to Friday
- Perform all duties in compliance with Patheon quality systems, SOPs, and Good Manufacturing Practices (GMP).
- The Director, Practical Process Improvement (PPI),…
- BioVectra Inc.Charlottetown, PE C1E 0A1
- $130,944–$204,600 a year
- Full-time
- Day shift
- Provide strategic quality leadership and influence across teams to drive a proactive quality culture and effective risk-based approaches.
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- Profound MedicalMississauga, ON L4W 5K5
- $110,000–$140,000 a year
- Full-time
- Minimum 7-10 years medical device experience; or equivalent combination of education and experience.
- Ensure incoming material inspection aligns with supplier…
- Applied Pharmaceutical InnovationEdmonton, AB T6N 1H1
- Full-time
- Paid time off
- RRSP match
- Work from home
- We encourage our employees to prioritize their well-being and enjoy quality time away from work.
- API offers a generous paid time off (PTO) policy that includes…
Senior Pharmaceutical Quality Assurance Manager
Easily applyUrgently hiringCRL SynergyCalgary, AB- Full-time +1
- Tuition reimbursement
- Vision care
- Dental care
- On-site gym
- Extended health care
- On-site parking
- Quality assurance: 1 year (preferred).
- To actively participate in projects with the Engineering team, Technical team and GMP Operations for drugs, medical…
Directeur(trice) qualité
Easily applyNewPuzzle Medical Devices® inc.Montréal, QC H4C 2Z6- Full-time +1
- Vision care
- Dental care
- Stock options
- Life insurance
- Disability insurance
- On-site gym
- Se joindre à Puzzle Medical, c’est faire partie d’une équipe engagée à améliorer le traitement de l’insuffisance cardiaque avancée.
- Options d'Achats d'Actions.
- Recrutement GK Inc.Laval, QC
- From $90,000 a year
- Full-time
- Monday to Friday
- RRSP
- On-site parking
- Journée d’absence illimitée et payée;
- Diriger et soutenir les audits internes et externes ainsi que les inspections FDA, Santé Canada et clients.
View similar jobs with this employerSiemens HealthineersOttawa, ON- $123,500–$173,500 a year
- Full-time
- Minimum of 15 years of progressive R&D product development leadership experience in the medical device or in vitro diagnostics (IVD) space.
- IQVIAMississauga, ON
- $108,500–$155,000 a year
- Full-time
- Ensure consistent and outstanding quality against department deliverables.
- 7-10 years of relevant experience, including experience establishing and managing a…
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- Kardium Inc.Burnaby, BC
- $102,000–$120,000 a year
- Permanent
- At least 8 years of engineering experience in a technical, multi-disciplinary environment; experience with medical devices or similarly regulated industries is…
- AbCelleraVancouver, BC
- $124,000–$155,000 a year
- Championing continuous improvement initiatives that elevate quality performance, compliance, and operational excellence site-wide.
- AbCelleraVancouver, BC
- $124,000–$155,000 a year
- Championing continuous improvement initiatives that elevate quality performance, compliance, and operational excellence site-wide.
Senior Manufacturing Quality Engineer
Easily applyVitalBioOakville, ON L6H 1M5- $130,000–$150,000 a year
- Permanent
- The Senior Manufacturing Quality Engineer is a technical leader responsible for ensuring manufacturing processes consistently produce safe, effective, and high-…
- StrykerHamilton, ON L9H 7L8
- $72,400–$96,600 a year
- Full-time
- Identify improvements and inputs into the quality planning process.
- Minimum 3+ years’ experience in regulatory affairs and/or quality assurance.
- View all Stryker jobs - Hamilton jobs - Senior Quality Specialist jobs in Hamilton, ON
- Salary Search: Senior Specialist, Operations Quality salaries
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Job Post Details
Senior Director / Site Quality Head - Canada - job post
Location
Benefits
Pulled from the full job description
- Employee stock purchase plan
- Dental care
- Life insurance
- Employee assistance program
- Disability insurance
Full job description
We Are Teva
Our Team, Your Impact
The Site Quality Head provides strategic and operational leadership for all Quality functions across Manufacturing, Packaging, Importation, and Laboratory Operations. This role is accountable for fostering a strong quality culture, ensuring compliance with regulatory requirements, and maintaining the highest standards of product quality and patient safety.
Key responsibilities include oversight of quality systems and processes, including but not limited to:
- Development, implementation, and execution of quality procedures and standards
- Establishment Licensing compliance
- Quality on the Floor activities, audits, and batch disposition/release
- Management of laboratory investigations, deviations, complaints, and nonconformances
- CAPA development, implementation, and effectiveness monitoring
- Quality metrics, trending, and performance reporting
- Validation program compliance
- Oversight of equipment, facilities, and utility systems to ensure adherence to established quality requirements
The role is responsible for leading the development, standardization, implementation, monitoring, and continuous improvement of Quality Systems, compliance programs, industry best practices, and corporate quality initiatives. The successful candidate will drive proactive quality and compliance improvements while strengthening a culture of operational excellence and Good Manufacturing Practice (GMP) compliance.
This position also serves as the Senior Person In Charge (SPIC) for Controlled Drug Substances and Narcotics.
How You’ll Spend Your Day
- Lead the site's Quality organization, including Quality Assurance, Quality Control, Microbiology, Quality Systems, and Quality Compliance.
- Ensure a robust and continuously improving Quality Management System (QMS) is maintained.
- Ensure products are manufactured, released, and distributed in compliance with cGMP requirements and approved regulatory specifications.
- Serve as the highest-ranking quality authority on site with independent decision-making responsibility regarding product quality and potential market actions.
- Assess, manage, and mitigate quality risks to ensure products are safe, effective, and compliant before reaching patients.
- Partner with business leaders to ensure a reliable and compliant supply of products.
- Develop, implement, and continuously improve the Site Quality Program in collaboration with the Site General Manager and Corporate Quality leadership.
- Oversee the collection, analysis, and communication of quality data and performance metrics to site leadership, Corporate Quality, and key internal and external stakeholders.
- Direct Quality Control laboratory operations, including analytical method transfers, testing, and approval or rejection of raw materials, packaging components, in-process materials, and finished products.
- Champion a sustainable culture of quality by promoting accountability, open communication, continuous improvement, and employee engagement.
- Build and maintain strong partnerships with the site leadership team and cross-functional stakeholders.
- Act as a strategic business partner to Supply Chain, Project Management, R&D, Manufacturing Sciences & Technology (MS&T), and Commercial teams to achieve business objectives and project milestones.Provide leadership and expert support during internal audits, customer inspections, and regulatory inspections.
- Ensure Quality KPIs meet established targets and that CAPA commitments are implemented on time, with effectiveness verified through ongoing monitoring.
- Develop, manage, and oversee the annual Quality Operations budget while optimizing resources and organizational effectiveness.
- Provide quality oversight for two pharmaceutical manufacturing sites located in the United States.
- Travel approximately 5% within the United States.
Your Skills and Experience
- Canadian university degree, or a degree recognized as equivalent by a Canadian university, in Chemistry, Chemical Engineering, Biology, Pharmacy, or a closely related life sciences discipline. Preferred: Master's degree or equivalent advanced degree in Chemistry, Biology, Pharmacy, or a related scientific field.
- Minimum of 10 years of progressive pharmaceutical manufacturing quality leadership experience.
- Extensive knowledge of cGMP requirements and expectations from major global regulatory authorities, including Health Canada, the U.S. FDA, and the European Medicines Agency (EMA).
- Strong understanding of pharmaceutical manufacturing, packaging, technology transfer, quality systems, and regulatory compliance requirements.
- Comprehensive knowledge of Health Canada, FDA, EU, and ICH regulations and guidelines, as well as Chemistry, Manufacturing, and Controls (CMC) content for regulatory submissions.
- Deep understanding of pharmaceutical production processes, product lifecycle management, equipment qualification, validation programs, and manufacturing technologies.
- Demonstrated experience leading and preparing for regulatory inspections, including GMP and pre-approval inspections conducted by the FDA and Health Canada.
- Proven expertise in Quality Systems management and continuous improvement initiatives.
- Strong leadership track record with experience building, developing, coaching, and inspiring large, high-performing teams.
- Excellent communication, stakeholder management, and strategic leadership capabilities.
How We’ll Take Care of You
At Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! Beyond base pay, Teva also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us. As part of our commitment to well-being, employees may have access to:
- Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life Insurance
- Employee Assistance Program & Virtual Health Programs
- Retirement Savings Programs
- Employee Stock Purchase Plan (ESPP)
- Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
- Education Assistance Program
- Recognition programs such as Employee Service Awards
- Employee Discounts
- And much more!
More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy and Teva Canada may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing for relevant skills, professional experience, and education, that best match the posted job qualifications. It is important to note that all final decisions in this process are made by a member of the hiring team.