Director, Quality Assurance & Compliance

ORA Partenaires; Winnipeg; On-site; CAD 150,000 - 200,000; Full time

Job summary

Emergent BioSolutions in Winnipeg seeks a Director of Quality Assurance to lead QA Operations, Quality Systems, and QA Validation. You will ensure products and validation activities meet GMP standards, Health Canada, FDA, and other requirements, while guiding inspection readiness and continuous improvement.

This role directs budget, strategic quality initiatives, and cross-functional collaboration with manufacturing.

Qualifications

• Bachelor’s degree in Science, Pharmacy, Engineering, or a related field. An advanced degree is considered an asset.
• Minimum of ten (10) years of progressive experience in Quality, Regulatory, or GMP operations, including senior management and people leadership.
• Ability to maintain an enterprise mindset and apply an organizational lens to decisions.
• Excellent communication, negotiation, interpersonal, management, and organizational skills.
• Demonstrates a strong commitment to teamwork, empowerment, and innovation to drive performance.
• Builds, maintains, and navigates relationships with stakeholders at all levels of the organization, including influencing senior leaders on matters of significance.
• Translates technical details, regulatory and quality standards, and business judgment into clear requirements and actionable priorities.
• Applies sound decision making using cause-and-effect analysis, corrective actions, and preventive approaches.

Responsibilities

• Leads QA Operations, Quality Systems, and QA Validation teams.
• Ensures products, services, and validation activities comply with corporate quality standards, GMP requirements, and applicable regulatory expectations, while remaining aligned with the company’s business strategy.
• Establishes operational plans with clear objectives aligned to Global Quality and Site Operational Plan goals.
• Oversees implementation of the Global Quality Manual and master batch records, and manages quality metrics.
• Directs key quality processes, including approval or rejection of intermediates, bulk products, and finished products; review of test results; evaluation of batch and production records.
• Works with Global Quality team on development, implementation, and maintenance of global quality systems.
• Ensures timely completion of GMP commitments to regulatory authorities.
• Creates and manages the department’s annual budget, including resource planning and prioritization.
• Champions change and continuous improvement to strengthen quality system effectiveness.
• Partner with the manufacturing team on operational initiatives and development projects.
• Leads investigation and escalation processes for significant quality events, coordinating with cross-functional teams.

Education

Bachelor’s degree in Science, Pharmacy, Engineering, or a related field. An advanced degree is considered an asset.

Job description

Emergent BioSolutions in Winnipeg seeks a Director of Quality Assurance to lead QA Operations, Quality Systems, and QA Validation. You will ensure products and validation activities meet GMP standards, Health Canada, FDA, and other requirements, while guiding inspection readiness and continuous improvement.

This role directs budget, strategic quality initiatives, and cross-functional collaboration with manufacturing.