Pharma Senior Manager Quality – AstraZeneca

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.

This opening is particularly relevant for professionals searching for Pharma Jobs in Canada with experience in Quality Assurance, pharmaceutical compliance, product release, deviations, CAPA, change control, audits, and regulatory inspections.

Company:
AstraZeneca / Alexion

Job Title:

Senior Manager, Country Quality – Canada

Location:

Mississauga, Ontario, Canada
Job Type: Full-Time
Job : R-261385
Industry: Pharmaceutical / Biotechnology
Department:
Quality Assurance

Experience:

6+ years of pharmaceutical QA/Compliance experience

Education:

Bachelor’s degree in Life Sciences or Pharmacy
Salary: CAD $88,296.80 – $ per year, plus applicable bonus and benefits

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.

For professionals monitoring Pharma Jobs in Canada, 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.

The Senior Manager, Country Quality will be responsible for managing and maintaining the local pharmaceutical Quality Management System. Key responsibilities may include:

• 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.

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,…