Sr Director, Quality Auditing (Internal Audits)

We are currently looking to fill a Sr Director of Internal Quality Auditing position. This position is responsible for providing professional expertise, leadership, oversight and planning for the Regeneron Internal Quality Auditing function, with primary emphasis on GMP and Quality audits that may impact GMP operations and/or products. Internal Quality Auditing is responsible for maintaining the internal audit program and performing internal audits for Regeneron global manufacturing operations.

In this role, a typical day might include the following:

• Ensure team members maintain 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.).

• Communicate industry trends as they pertain to regulatory agency findings, expectations and warning letters.

• Builds and leads relationships with partners, regulators and internal team members.

• Coordinates and advises the internal audit programs and audit schedules for GMP and quality audits.

• Continually assesses scalability and capacity of resources and respective operations.

• Strategically plans, prioritizes and leads resources to meet audit schedules and company, QA and departmental goals, objectives and quality results, translates goals of the company into departmental objectives, connecting the dots across the company and the global network.

• Provides direction on auditing matters and provides leadership, mentorship and supervision to auditing management and personnel; promotes a GxP and Quality approach.

• Supervises the development of auditing team members and coaches and mentors to drive succession planning and ensure business continuity.

• Coordinates the metrics developed to measure strategy and test the health of Quality Auditing systems and processes; oversees and reviews Right to Operate (RTO) metrics presented to Sr Leadership.

• Participates in inspection readiness and inspections as needed.

• Provides oversight to ensure safety and operational standards are maintained.

This role may be for you if you

• Are knowledgeable in industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)

• Can set the course for the future; reassess auditing processes and procedures periodically for continuous improvement opportunities and drives departments for efficient performance; continually improve in a strategic and thoughtful manner.

• Excel in a quality driven organization

• Have an understanding of biologics manufacturing operations

To be considered for this role you must hold a Bachelors degree in a life sciences subject area or related field and the following amount of experience in pharmaceutical/biotechnology industry experience, including experience with Quality Systems and auditing, for each level:

• Senior Director - 15+ years

• Executive Director - 20+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$196,100.00 - $385,700.00