Associate Director, Quality Compliance

Role Summary

The Associate Director, Quality Compliance will lead the development, implementation and management of external and internal GxP audits (GLP, GCP and GMP). This role covers the full audit lifecycle, from developing a risk-based annual audit plan to monitoring and presenting audit program performance and maturity. The position also supports due diligence supplier assessments and ongoing monitoring of supplier inspection performance. Reports to the Executive Director, Quality and Compliance.

Responsibilities

• Implement and deliver a risk-based and data-driven strategic audit plan.
• Manage all aspects of the audit lifecycle including scheduling, planning, agenda issuance, audit execution, report issuance, response evaluation, request clarification, observation report creation, timely closure and tracking of supplier audit CAPA(s), and audit closure.
• Collaborate with cross-functional departments to gather key information and feedback prior to conducting supplier audits to ensure risk-based agendas and appropriate subject matter experts are involved.
• Coordinate with suppliers to schedule audits, request documentation, provide formal audit outcomes, obtain responses and issue formal audit closure notices.
• Ensure CAPAs address compliance concerns in line with observation classification, overall risk and industry practices.
• Oversee contractor auditors, monitoring performance and adherence to processes to maintain consistency in observation writing, classification, status, and risk.
• Develop, implement, and maintain systems, procedures and templates to monitor, evaluate and improve the auditing process.
• Gather and report GxP audit performance measures and maturity at senior leadership meetings (e.g., quarterly Management Review).

Qualifications

• 13+ years of relevant experience in the pharmaceutical industry; advanced degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering) preferred
• Background in Biologics Operations (Manufacturing, Quality Control, Quality Assurance)
• Expert level experience in scheduling, planning, execution and follow-up on audits
• Excellent verbal, written, and interpersonal skills
• Thorough knowledge of compliance requirements and understanding of current global and regional trends in compliance
• Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205, 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; Health Canada R.S.C., 1985, F-27, Section 30; ICH, ISO, PIC/S and USP/NF, EP, and JP standards as applicable
• Experience in leading investigations, root cause analysis, and CAPA implementation preferred
• Excellent analytical, problem-solving, and decision-making skills preferred
• Strong leadership and project management abilities preferred

Skills

• Auditing and compliance
• GxP knowledge (GLP, GCP, GMP)
• CAPA development and closure
• Risk assessment and data-driven planning
• Vendor and supplier auditing
• Cross-functional collaboration
• Investigations and root-cause analysis
• Communication and stakeholder management

Education

• Advanced degree in a relevant field preferred (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering)

Additional Requirements

• Position is fully remote with up to 20% travel domestically and/or internationally