Associate Director Quality Auditing

3 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

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.

Education and Experience:

  • 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.

#LI-Onsite #JOBSIEPR #REGNIEQA #IRELIM

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. #J-18808-Ljbffr

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