Regeneron

The GMP Internal Auditor involves maintaining and continuously improving the auditor training program, as well as planning, coordinating, and performing audits across various stages. A comprehensive understanding of USA and EU GxP regulations is essential, with a focus on aseptic filling, primary packaging and labeling, device assembly, and serialization operations.

As a GMP Internal Auditor, a typical day might include the following:

• Maintain expertise in audit criteria, including internal company policies, procedures, and relevant local and international regulations, standards, and guidelines.
• Develop and maintain departmental processes and procedures to ensure compliance with current regulatory requirements.
• Monitor industry trends concerning regulatory agency findings, expectations, and warning letters.
• Coordinate the auditor training program, including training, qualification, and continuing education for auditors.
• Assist with audit scheduling and assignments and support auditor activities.
• Own the oversight, selection, training, onboarding, and assessment of proxy auditors.
• Review audit documentation for training purposes, peer review, approval, and closure.
• Conduct supplier/external audits and evaluate systems, processes, procedures, and records against applicable GxPs and audit criteria.
• Collaborate with Procurement, External Manufacturing, Quality, audit clients, and other partners regarding supplier/external audits.
• Prepare accurate and high-quality audit reports and documentation, ensuring compliance with company and department procedures and timelines.
• Provide guidance for developing corrective and preventive actions aligned with GxP requirements and industry standards.
• Participate in inspection readiness activities, inspections, partner audits, and internal audits as needed.

This role may be for you if:

• You are able to interpret policies, standards, and regulations, and then evaluate potentially critical problems not covered
• You can ensure that we are following written procedures, and exercise judgment in evaluating quality systems, processes, procedures, and protocols for compliance
• You have the ability to stand and walk for extended periods of time
• You enjoy travel, domestic and international, 25% of your time

In order to be considered for this position, you must hold a BS/BA and

• Staff: 10+ years of related experience in Med Device/Biotech/Pharmaceutical industry;
• Senior Staff: 12+ years of related experience in Biotech/Pharmaceutical industry;
• A minimum of 10+ years of Quality Management experience in a GMP environment with prior auditing experience; extensive experience in auditing aseptic filling and primary packaging and labeling is required.
• Experience in device assembly and serialization is preferred.
• Knowledge in CFR 210, 211, ICH guidelines Q6A and Q6B, ISO 13485 and/or EU GMP Annex 1 required
• May consider experience in lieu of education; level decided upon completion of an interview process

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)

$106,400.00 - $173,400.00