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 key position is responsible for all aspects of the audit lifecycle from development of Jade’s risk-based annual audit plan to monitoring and presentation of the performance and maturity of the audit program. In addition, this individual will support due diligence supplier assessments and continuous monitoring of supplier inspection performance. This position will report to the Executive Director, Quality and Compliance. This is a fully remote role with up to 20% domestic and/or international travel as a key position requirement.

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 directly with cross-functional departments to gather key information and feedback prior to conducting supplier audits to ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
• Communicate directly with supplier to schedule audit, request required documentation prior to audit commencement, provide formal audit outcome, obtain response(s) and provide formal notice of audit closure.
• 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 with audit report observation writing, classification, status, and overall risk.
• Own the development, implementation, and maintenance of systems, procedures and templates to assist in the monitoring, evaluation and improvement of the auditing process.
• Gather and report GxP audit performance measures and maturity at senior leadership meetings such as 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 an 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; and 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 and principals 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