Senior Director QA / RA

Job Description

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We are seeking an experienced and strategic Senior Director of Quality Assurance & Regulatory Affairs (QA / RA) to lead quality and compliance efforts at our Halifax-based facility. The ideal candidate will have a strong background in IVD (in vitro diagnostics), blood typing reagents, or biologics manufacturing, and will be passionate about maintaining the highest standards of regulatory compliance and operational excellence in a regulated environment.

Key Responsibilities

Quality Assurance (QA)

• Lead the development, implementation, and continual improvement of the Quality Management System (QMS) in accordance with ISO 13485, CMDR, and other applicable regulations.
• Oversee internal and external audits, including Health Canada and international regulatory inspections.
• Manage product release, batch records, change control, CAPAs, and non-conformances.
• Ensure appropriate validation of processes, equipment, and analytical methods.
• Provide leadership and mentorship to the QA team; ensure training and compliance throughout the organization.

Regulatory Affairs (RA)

• Develop and execute global and domestic regulatory strategies for product submissions and approvals (e.g., Health Canada, FDA, EU IVDR).
• Prepare, review, and submit regulatory dossiers, renewals, and post-market surveillance reports.
• Ensure regulatory compliance for labeling, advertising, and promotional materials.
• Maintain up-to-date knowledge of changes in regulatory landscapes and assess impact on current operations and products.

Qualifications

• Bachelor’s or Master’s degree in Biology, Biochemistry, Medical Laboratory Science, or a related field.
• Minimum 10 years of experience in Quality Assurance and Regulatory Affairs, with at least 5 years in a leadership capacity.
• Direct experience with Health Canada, FDA (21 CFR Part 820), ISO 13485, and ideally EU IVDR regulations.
• Demonstrated experience in a manufacturing environment producing biologics, diagnostics, or similar regulated products.
• Strong understanding of risk management (ISO 14971) and design control.
• Excellent organizational, communication, and leadership skills.
• Certification(s) such as RAC, ASQ CQA, or related credentials are considered an asset.

Preferred Experience

• Familiarity with transfusion diagnostics, blood grouping reagents, or specialty immunohematology products.
• Experience working within a global regulatory framework and cross-functional environments.
• Knowledge of Good Manufacturing Practices (GMP) for biologics or IVDs.

Additional Information

Seniority level: Director

Employment type: Full-time

Job function: Quality Assurance and Management

Industries: Biotechnology Research, Hospitals and Health Care, Medical Equipment Manufacturing

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