Principal Gmp Auditor - Post Audit (Remote)

We are currently looking to fill a Principal GMP Auditor position. This role is responsible for planning, coordinating and performing pre and post-audit activities for consultant-assigned audits, performing post-audit activities (e.g., review of responses) for assigned audits performed by Regeneron Auditors, performing Quality Audit Survey Assessments, issuing Surveys and assessing completed surveys. Responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP and Quality audits that may impact Regeneron operations and/or product.

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

• Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and 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, ICH, WHO and IPEC Guidelines, etc.)

• Review industry trends regarding regulatory agency findings, expectations and warning letters

• Collaborate with Procurement, External Manufacturing, Quality, audit clients and other partners with respect to supplier/external audits

• Perform peer review of supplier audit reports, to ensure that audit findings are clear and concise and meet the requirements of Quality Auditing procedures, and applicable regulatory requirements

• Review of audit responses; ensure requirements for audit documentation and auditee responses are met

• Prepare written audit documents in accordance with company and department procedures and requirements; ensure the quality and accuracy of all audit documentation; ensure timelines for audits are met

• Perform and maintain all required training and annual GMP training within required timelines

• Provide support in the development of corrective and preventive actions based on GxP requirements and industry standards

• Assist with training, onboarding and assessment of proxy auditors

• Assist with the oversight, selection, training, onboarding and/or consultant auditor performance assessments

• Participate in inspection readiness, inspections/partner audits, and internal audits as needed

• Preform Mock Audits

• Assist management with the development and maintenance of the auditor continuing education program

This role might be for you if you:

• Are able to interpret policies, standards, and regulations, and then evaluate potentially critical problems not covered

• Can ensure that we are following written procedures, and exercise judgment in evaluating quality for compliance

• Have the ability to stand and walk for extended periods of time

• Enjoy travel, domestic and international, 10% of your time

• Can accommodate a work schedule of 8:00 am to 5:00 pm Eastern time

To be considered for this role you must hold a Bachelors degree with the following amount of experience in the Biotech/Pharmaceutical industry, audit experience in GMP environment preferred for each level.

• Sr GMP Auditor: 5+ years

• Principal GMP Auditor: 8+ years

Other proven experience may be considered in lieu of degree. Level is determined based on qualifications relevant to the role.

#REGNQA

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.

$88,500.00 - $169,000.00Employment Type: Employee