At a Glance
- Tasks: Lead quality assurance efforts in the pharmaceutical industry and ensure compliance with regulations.
- Company: Join AstraZeneca/Alexion, a leader in the pharmaceutical sector.
- Benefits: Competitive salary, bonuses, and comprehensive benefits package.
- Other info: Great opportunity for career advancement in a dynamic industry.
- Why this job: Make a significant impact on healthcare by ensuring product quality and safety.
- Qualifications: 6+ years in pharmaceutical QA and a degree in Life Sciences or Pharmacy.
The predicted salary is between 29680 - 115889 $ per year.
Are you an experienced pharmaceutical Quality Assurance professional looking for an opportunity in Canada? The Senior Manager, Country Quality position at AstraZeneca/Alexion in Mississauga, Ontario, is an excellent opportunity for professionals with strong experience in pharmaceutical quality, GMP compliance, Quality Management Systems (QMS), and regulatory requirements.
About the Position
AstraZeneca/Alexion is seeking a highly experienced Quality professional to support its Canadian operations. The Senior Manager, Country Quality will play an important role in maintaining the company’s pharmaceutical Quality Management System and ensuring that products and business activities comply with applicable GMP and GxP requirements. This role provides an opportunity to work in a senior Quality position involving pharmaceutical compliance, product release, regulatory inspections, quality systems, and cross-functional collaboration. The successful candidate will work closely with Supply Chain, Regulatory Affairs, Pharmacovigilance, Quality teams, and other business functions to maintain a robust quality system and support the safe and compliant supply of pharmaceutical products.
Key Responsibilities
- Managing Quality Management System activities for the Canadian organization.
- Supporting deviations, investigations, CAPA, change controls, and quality documentation.
- Managing quality‑related training and documentation systems.
- Supporting product recall and self‑inspection activities.
- Participating in Quality Management Reviews.
- Supporting pharmaceutical product release and lot‑release activities.
- Coordinating product release activities with Supply Chain.
- Supporting regulatory inspections, including Health Canada GMP inspections.
- Developing and implementing quality improvement and remediation plans.
- Ensuring compliance with applicable GMP/GxP requirements.
- Providing Quality support for new product launches.
- Working with Regulatory Affairs and Pharmacovigilance teams.
- Supporting supplier and customer qualification activities.
- Reviewing and managing quality agreements with external partners.
- Providing expert Quality input to business and technical teams.
Qualification Requirements
Candidates interested in this opportunity should generally have a Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline. An advanced degree may be advantageous for a senior Quality position. The position requires approximately 6 or more years of hands‑on Quality Assurance, Quality Compliance, or related experience within the pharmaceutical or biotechnology industry. Candidates should have strong knowledge of pharmaceutical GMP and GxP requirements. Experience with Health Canada regulations will be particularly valuable for this Canadian Quality position. Experience involving sterile products, biological products, finished pharmaceutical products, packaging and labeling, pharmaceutical testing, distribution, or product release can provide an advantage. Knowledge of international regulatory requirements, including FDA, EMA, or other major health authority requirements, may also be beneficial.
Skills Preferred for the Role
- Pharmaceutical Quality Assurance
- Quality Management Systems
- GMP and GxP compliance
- CAPA management
- Deviation and investigation management
- Change control
- Product release
- Quality risk management
- Regulatory inspection readiness
- Health Canada GMP requirements
- Supplier qualification
- Quality agreements
- Audit management
- Quality documentation
- Cross-functional leadership
This makes the position especially attractive to experienced QA professionals researching Pharma Jobs in Canada and looking to advance into a senior Quality leadership role.
Why This Opportunity Is Important
Canada has a well‑established pharmaceutical and biotechnology industry, creating opportunities for professionals with strong GMP, Quality Assurance, Regulatory Affairs, QC, manufacturing, and compliance experience. Among available Pharma Jobs in Canada, senior Quality positions can be particularly attractive to professionals who have experience with pharmaceutical manufacturing and international regulatory standards. The Senior Manager, Country Quality role combines technical Quality knowledge with leadership, regulatory compliance, product release, and business support responsibilities.
Salary and Benefits
The reported salary range for this position is approximately CAD $88,296.80 to CAD $115,889.55 annually, with applicable bonus and benefits. Actual compensation may depend on experience, qualifications, location, and company policies.
Final Thoughts
The Canadian pharmaceutical sector continues to provide opportunities for experienced professionals across Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Validation, Microbiology, and GMP compliance. If you are an experienced pharmaceutical QA professional with strong knowledge of QMS, GMP, CAPA, deviations, product release, audits, and regulatory requirements, this Senior Manager, Country Quality position may be worth considering.
Senior Manager Quality – Canada in Mississauga employer: Pharmaguidances
AstraZeneca/Alexion is an exceptional employer located in Mississauga, Ontario, offering a dynamic work culture that prioritizes collaboration and innovation in the pharmaceutical industry. Employees benefit from competitive salaries, comprehensive benefits, and ample opportunities for professional growth within a supportive environment that values quality and compliance. Joining AstraZeneca means being part of a leading organization committed to advancing healthcare while fostering a culture of excellence and integrity.
