Associate Director Quality Auditing
تفاصيل الوظيفة
Responsible for providing professional expertise, leadership, oversight and assisting with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for maintaining the external audit program and performing external audits for Regeneron IOPS, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or products. Essential Duties and Responsibilities may include, but are not limited to, the following:
- Maintains professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards and ICH, WHO and IPEC Guidelines, etc.).
- Monitors and communicates industry trends as they pertain to regulatory agency findings, expectations, and warning letters.
- Collaborates with Procurement, External Manufacturing, Drug Product Quality, QA & Operations and other team members and audit clients pertaining to supplier audits
- Develops strategies to achieve what needs to be done; prioritizes and manages resources to meet audit schedules, company and departmental goals and objectives, and quality deliverables.
- Provides guidance and direction on auditing matters, and provides leadership, guidance and supervision to auditing personnel; promotes a GxP and Quality mindset at all levels.
- Manages the external IOPS audit program, including scheduling, planning, audit assignments and post audit activities; leads/participates in audits, as necessary.
- Manages and supports the selection, training, onboarding, performance assessments and audit performance of external proxy auditors (consultants).
- Coaches, develops and mentors Quality Auditing (GMP) employees to drive succession planning and business continuity planning.
- Compiles, maintains metrics to measure the performance and health of Quality Auditing systems and processes and presents metrics to senior department management
- Ensures auditing processes and procedures meet the minimum regulatory requirements and current industry standards, ensures expectations and procedures are followed, and ensures deviations and changes, if any, are documented and assessed in accordance with IOPS processes and procedures.
- Works in and on the business; translates ambiguity into actionable steps and prevents deviations and fires using effective and out of the box problem solving.
- Reassesses auditing processes and procedures periodically for continuous improvement opportunities to ensure optimal performance.
- Ensures the training and qualification program for auditing employees is appropriate and adequately maintained.
- Accountable for the performance and results of the team and the external audit programs
- Participates in inspection readiness and inspections as needed.
- Ensures safety and operational standards are maintained.
- Leads and/or participates in projects and initiatives as assigned by management.
- Degree in a life sciences subject area or related field (chemistry, biology, or pharmacy preferred) and 12+ years of pharmaceutical/biotechnology industry experience with Quality Systems and auditing and 2 years managerial experience, or equivalent combination of education and experience.
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