Senior Director QA / RA

Job Description

<p><b>1 day ago Be among the first 25 applicants</b></p><p>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.</p><h3>Key Responsibilities</h3><h3>Quality Assurance (QA)</h3><ul><li>Lead the development, implementation, and continual improvement of the Quality Management System (QMS) in accordance with ISO 13485, CMDR, and other applicable regulations.</li><li>Oversee internal and external audits, including Health Canada and international regulatory inspections.</li><li>Manage product release, batch records, change control, CAPAs, and non-conformances.</li><li>Ensure appropriate validation of processes, equipment, and analytical methods.</li><li>Provide leadership and mentorship to the QA team; ensure training and compliance throughout the organization.</li></ul><h3>Regulatory Affairs (RA)</h3><ul><li>Develop and execute global and domestic regulatory strategies for product submissions and approvals (e.g., Health Canada, FDA, EU IVDR).</li><li>Prepare, review, and submit regulatory dossiers, renewals, and post-market surveillance reports.</li><li>Ensure regulatory compliance for labeling, advertising, and promotional materials.</li><li>Maintain up-to-date knowledge of changes in regulatory landscapes and assess impact on current operations and products.</li></ul><h3>Qualifications</h3><ul><li>Bachelor’s or Master’s degree in Biology, Biochemistry, Medical Laboratory Science, or a related field.</li><li>Minimum 10 years of experience in Quality Assurance and Regulatory Affairs, with at least 5 years in a leadership capacity.</li><li>Direct experience with Health Canada, FDA (21 CFR Part 820), ISO 13485, and ideally EU IVDR regulations.</li><li>Demonstrated experience in a manufacturing environment producing biologics, diagnostics, or similar regulated products.</li><li>Strong understanding of risk management (ISO 14971) and design control.</li><li>Excellent organizational, communication, and leadership skills.</li><li>Certification(s) such as RAC, ASQ CQA, or related credentials are considered an asset.</li></ul><h3>Preferred Experience</h3><ul><li>Familiarity with transfusion diagnostics, blood grouping reagents, or specialty immunohematology products.</li><li>Experience working within a global regulatory framework and cross-functional environments.</li><li>Knowledge of Good Manufacturing Practices (GMP) for biologics or IVDs.</li></ul><h3>Additional Information</h3><p>Seniority level: Director</p><p>Employment type: Full-time</p><p>Job function: Quality Assurance and Management</p><p>Industries: Biotechnology Research, Hospitals and Health Care, Medical Equipment Manufacturing</p><p>Referrals increase your chances of interviewing at Biotech Partners by 2x.</p><p>Sign in to set job alerts for “Director of Quality Assurance” roles.</p><p>Other openings include:</p><ul><li>Performance & Quality Manager (Any Location in Canada - Remote)</li><li>Quality Manager- Supply Chain (Permanent)</li></ul>
#J-18808-Ljbffr