Pharma Jobs in Canada: Senior Manager Quality – AstraZeneca

Pharmaguidances; Mississauga; On-site; CAD 87,000 - 117,000; Full time

Job summary

AstraZeneca/Alexion Canada in Mississauga, Ontario, seeks a Senior Manager, Country Quality to lead the local Quality Management System and ensure GMP/GxP compliance across operations, product release, deviations, CAPA, change control, and regulatory inspections.

The role collaborates with Supply Chain, Regulatory Affairs, Pharmacovigilance, and Quality teams to maintain robust quality systems and support safe, compliant product supply for Canada.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy or related discipline; advanced degree advantageous.
• 6+ years of hands-on QA/Compliance experience in pharma/biotech.
• Strong knowledge of GMP and GxP; Health Canada regulations valuable.

Responsibilities

• Maintain local Quality Management System and ensure GMP/GxP compliance.
• Support deviations, investigations, CAPA, change controls, and documentation.
• Assist product release and lot-release activities; coordinate with Supply Chain.
• Prepare for regulatory inspections and manage quality agreements with partners.

Skills

GMP compliance

QMS management

CAPA management

Regulatory inspections

Deviation investigations

Change control

Product release

Quality documentation

Cross-functional leadership

Education

Bachelor’s degree in Life Sciences or Pharmacy

Job description

Senior Manager, Country Quality – AstraZeneca/Alexion Canada

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.

Job Details

Company: AstraZeneca / Alexion
Job Title: Senior Manager, Country Quality – Canada
Location: Mississauga, Ontario, Canada
Job Type: Full-Time
Job ID: 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 – $115,889.55 per year, plus applicable bonus and benefits

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.

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.

Key Responsibilities

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.

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

Professionals applying for this position should have strong knowledge and practical experience in areas such as:

• 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. It can therefore be relevant for Quality Managers, Senior QA professionals, Quality Compliance Managers, and other experienced pharmaceutical professionals.

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.

Professionals comparing Pharma Jobs in Canada should review the official vacancy carefully for the latest information regarding compensation, benefits, working arrangements, and eligibility requirements.

For candidates actively searching for Pharma Jobs in Canada, this opportunity represents a strong option for developing a career in pharmaceutical Quality Assurance, GMP compliance, and regulatory quality management.

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.

Keep checking Pharma Jobs in Canada on Pharmaguidances for additional opportunities in pharmaceutical manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Validation, Microbiology, and other life‑science functions.

Note: Job availability, salary, responsibilities, and application requirements can change. Candidates should verify the latest information on the official employer’s careers page before applying.