Senior Manager, Quality Assurance
- Whitchurch-Stouffville, ON, Canada
The typical hiring range for this position is $120,560-$150,700. · Full-time
Applications open in a new tab.
Job details
- Pay
- The typical hiring range for this position is $120,560-$150,700.
- Job type
- Full-time
- Apply by
- Education
- Bachelor’s degree
- Experience
- Minimum of 5 years of relevant experience in Quality Assurance within a pharmaceutical, biotechnology, or related regulated manufacturing environment.
- Posting language
- English
- Posted
Original job description
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
Our Team, Your Impact
We are seeking a highly experienced Senior Manager, Quality Assurance to lead Quality Assurance operations at our Stouffville manufacturing site. This role is responsible for providing leadership, technical expertise, and strategic direction to ensure all Quality Assurance activities are conducted in compliance with SOPs, GMP, and cGMP requirements.
The successful candidate will oversee quality systems, product investigations, product release activities, regulatory compliance, and team development while driving a culture of quality, accountability, and continuous improvement.
How You’ll Spend Your Day
- Lead and oversee investigations related to products manufactured at the site, ensuring compliance with regulatory requirements and company standards.
- Ensure investigations are thoroughly documented, maintained, and completed in a timely manner.
- Monitor and track corrective and preventive actions (CAPAs) to ensure effectiveness and compliance.
- Oversee the management and investigation of customer, healthcare professional, and regulatory product complaints.
- Provide expert guidance on quality procedures, SOPs, GMP, and cGMP requirements to Production and Quality teams.
- Maintain current knowledge of FDA and Health Canada regulations governing pharmaceutical manufacturing, packaging, testing, distribution, and quality systems.
- Oversee manufacturing batch record reviews, product release activities, document issuance, and document control processes.
- Act as the Site QA Ecosystem Lead, ensuring the successful implementation and maintenance of quality systems and learning management infrastructure.
- Manage retained sample programs for raw materials and finished products in accordance with regulatory requirements.
- Oversee returned goods processes and ensure only acceptable product is returned to inventory.
- Lead, coach, mentor, and develop Quality Assurance staff through performance management, career development, and succession planning initiatives.
- Participate in and support regulatory inspections and internal audits.
- Promote Environmental Health & Safety (EHS) programs, including hazard identification, incident investigations, root cause analysis, and corrective action implementation.
- Foster a culture of continuous improvement, quality excellence, and regulatory compliance.
- Bachelor's degree in a Science-related discipline required.
- Minimum of 5 years of relevant experience in Quality Assurance within a pharmaceutical, biotechnology, or related regulated manufacturing environment.
- Previous supervisory and people leadership experience required.
- Experience managing quality systems, investigations, audits, and regulatory compliance activities.
- Strong knowledge of SOPs, GMP, and cGMP requirements.
- Familiarity with FDA and Health Canada regulations.
- Experience with TrackWise, Oracle, LIMS, Smart QA, and Microsoft Office applications.
- Understanding of pharmaceutical manufacturing operations, HVAC systems, purified water systems, and statistical analysis.
- Strong leadership, coaching, and team development skills.
- Excellent written and verbal communication skills.
- Proven planning, prioritization, and organizational abilities.
- Strong analytical thinking and complex problem-solving capabilities.
- Ability to manage multiple priorities in a fast-paced environment.
- Effective interpersonal skills with the ability to influence and collaborate across functions.
- Strong attention to detail and commitment to quality and compliance.
- Travel as required.
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! The typical hiring range for this position is $120,560-$150,700. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package. 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!
Already Working @Teva?
Make sure to apply through our internal career site on Twist - your one-stop shop for career development
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
More about this job
Responsibilities
The Senior Manager, Quality Assurance will lead quality operations at the Stouffville manufacturing site, ensuring compliance with GMP and regulatory standards. They are responsible for overseeing product investigations, quality systems, and the development of the QA team to drive a culture of continuous improvement.
Requirements
Candidates must hold a Bachelor's degree in a science-related discipline and possess at least 5 years of relevant experience in a regulated pharmaceutical manufacturing environment. Strong knowledge of GMP/cGMP, regulatory compliance, and proven supervisory experience are essential for this role.
Skills
- Quality assurance
- GMP
- cGMP
- Regulatory compliance
- Product investigations
- CAPA management
- Team leadership
- SOP development
- FDA regulations
- Health Canada regulations
- Batch record review
- Quality systems
- Auditing
- Root cause analysis
- Performance management
- Strategic planning
Benefits
- Health insurance
- Dental insurance
- Disability insurance
- Life insurance
- Employee assistance program
- Virtual health programs
- Retirement savings programs
- Employee stock purchase plan
- Paid vacation
- Wellness days
- Care/sick days
- Teva days
- Volunteer days
- Education assistance program
- Employee service awards
- Employee discounts
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Management & Leadership
- Manufacturing
- Science & Research
Keywords
- Quality Assurance
- Pharmaceutical Manufacturing
- GMP
- cGMP
- FDA
- Health Canada
- TrackWise
- Oracle
- LIMS
- Smart QA
- SOP
- CAPA
- Root Cause Analysis
- HVAC
- Purified Water Systems
- Statistical Analysis
- Regulatory Compliance
- Quality Systems
- Batch Records
- Audits
- EHS
- Biotechnology
- Leadership
- Mentorship
- Performance Management
- Document Control
- Risk Management
- Quality Excellence
- Strategic Direction
- Manufacturing