Senior Manager, Country Quality (Canada)

Alexion Pharmaceuticals, Inc.; Mississauga; Hybrid; CAD 88,000 - 116,000; Full time

Benefits offered by this job

Flex benefits program

4 weeks paid vacation

Annual Personal Days

Job summary

Alexion Canada is seeking a Senior Manager, Country Quality to lead the QMS and serve as the primary quality contact for product release. The role requires extensive GMP expertise, Health Canada regulations, and the ability to drive QA across a global, matrix organization.

You will manage deviations, CAPAs, inspections, and quality improvements while coordinating with Regulatory Affairs, Pharmacovigilance, and Supply Chain. Hybrid in-office leadership with periodic travel is expected.

Qualifications

• Bachelor's Degree in life science or pharmacy; advanced degree preferred.
• 6+ years hands-on Quality Assurance / Compliance experience in pharmaceutical/biotech industry.
• Experience in sterile and biological finished product manufacturing, packaging/labelling, testing and distribution processes.
• In-depth knowledge of Health Canada GMP/GXP requirements; EMA/FDA/PMDA experience would be asset.
• Exceptional communication and interpersonal skills; ability to work globally in a matrix environment.
• Ability to influence management, peers and collaborators; adapt to changing compliance/business needs.

Responsibilities

• Maintain the QMS in line with Corporate Quality and Health Canada GMP requirements.
• Manage QA tasks including lot release activities.
• Coordinate with Supply Chain to prioritize lot release per business needs.
• Roll out and ensure compliance to global quality systems and SOPs at site level.
• Support Health Canada GMP inspections and remediation plans.
• Ensure compliance with vendor quality agreements and distribution requirements.
• Provide quality input for new product launches and cross-functional collaboration.

Skills

Quality assurance

Regulatory knowledge

Cross-functional collaboration

Communication skills

Global/matrix work experience

Ability to influence

Multi-tasking

Planning & organizational skills

Computer skills

Overnight travel readiness

Education

Bachelor's degree in life science or pharmacy

Job description

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

This is what you will do:

The Senior Manager, Country Quality will be responsible for managing the Corporate Quality Management System (QMS) within Alexion Canada. The candidate will be the primary Quality contact for product release and assigned QMS activities. This role requires strong experience in GMP, QMS and in-depth understanding of Health Canada GMP requirements.

You will be responsible for:

• Maintain the quality management system (QMS) in line with Corporate Quality and Health Canada GMP requirements, including but not limited to:

• Deviation Management, CAPA, Complaint Management, Change Control Management, Documentation Management, Training Management, Recall Management, Self-Inspection Management and Quality Management Review, etc.
• Responsible for managing QA related tasks including lot release activities in compliance with Health Canada GMP requirements.
• Coordinate with Supply Chain and relevant collaborators to prioritize lot release as per business needs.
• Manage the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards at the site level.
• Support coordination and management of Health Canada GMP inspections.
• Manage the review and implementation of Quality Improvement/remediation plans identified through Corporate/internal audits.
• Ensure that Alexion Policies and Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with local GMP/GXP guidelines.
• Support quality oversight and activities associated with new product launches.
• Support and collaborate with other functions (e.g., Pharmacovigilance, Regulatory Affairs) as required by providing Quality input and identify risks to the QMS.
• Authorizing the return to saleable stock of any returned medicinal products.
• Support the qualification and approval of suppliers and customers.
• Approving and maintaining quality agreements with vendors relating to wholesale distribution and/or transportation of medicinal products.

You will need to have:

• Bachelor's Degree in life science or pharmacy (advance degree preferred)
• 6 years+ of hands-on Quality Assurance / Compliance experience in the pharmaceutical/ biotech industry.
• Experience in sterile and biological finished product manufacturing, packaging/labelling, testing and distribution processes
• In-depth knowledge of Health Canada regulations and guidelines (EMA, FDA, PMDA experience would be an asset) pertaining to GMP/GXP required.
• Exceptional communication and interpersonal skills.
• Ability to work globally in a matrix environment.
• Ability to influence management, peers and collaborators.
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
• Ability to multi-task and prioritize work.
• Strong organizational ability.
• Demonstrable computer skills.
• Ability for occasional overnight travel as required.

We would prefer you to have:

Advanced degree preferable

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire?

#LI-Hybrid

Annual base salary for this position ranges from 88,296.80 to 115,889.55.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.