Associate Director, Quality Compliance

Role Summary

The Associate Director, Quality Compliance will lead the development, implementation and management of external and internal GxP (GLP, GCP and GMP) audits. This position is responsible for all aspects of the audit lifecycle from the development of a risk-based annual audit plan to monitoring and presenting the performance and maturity of the audit program. The role also supports due diligence supplier assessments and continuous monitoring of supplier inspection performance, reporting 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.
• Work with cross-functional departments to gather key information and feedback prior to conducting supplier audits to ensure the audit agenda is risk-based and includes appropriate internal and/or external subject matter experts.
• Communicate directly with suppliers to schedule audits, request required documentation prior to audit, provide formal audit outcomes, obtain responses and provide formal closure notices.
• Ensure CAPA(s) address compliance concerns identified during audits are commensurate with observation classification, overall risk and current biologics industry practices.
• Provide oversight and direction to contractor auditors, including monitoring performance and adherence to established processes to drive consistency in audit report observation writing, classification, status, and overall 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; an advanced degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering) is 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; as well as ICH, ISO, PIC/S and USP/NF, EP, and JP compendial 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

Additional Requirements

• Remote role with up to 20% domestic and/or international travel as a key position requirement.