Associate Director, Quality Compliance

13+ years of relevant experience in the pharmaceutical industry 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

Implement and deliver a risk-based and data-driven strategic audit plan. Manage all aspects of the audit lifecycle. Gather key information and feedback prior to conducting supplier audits. Communicate directly with supplier to schedule audit, request required documentation, provide formal audit outcome, obtain response(s) and provide formal notice of audit closure. Ensure CAPA(s) address compliance concerns identified during audits. Provide oversight and direction to contractor auditors. 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.