Principal GMP Auditor (Remote)

We are currently looking to fill a Principal GMP Auditor position. This role is responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.

In this role, a typical day might include the following:
• Scheduling, preparing, and conducting audits in support of GMP as advised
• Assembling and coordinating the activities of the audit team
• Performing audits in accordance with Regeneron standard operating procedures and quality policies
• Raising any compliance issues
• Communicating audit results to management and auditees through written audit reports
• Leading post-audit activities, and following up on any vital corrective and preventive actions by resolving any issues
• Assisting with hosting regulatory facility inspections by acting as a scribe and/or document reviewer
• Drafting and issuing periodic reports to site management as requested
• Assisting with training/orientation for new Quality Auditing staff

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 systems, processes, procedures, and protocols for compliance
• Have the ability to stand and walk for extended periods of time
• Enjoy travel, domestic and international, 50% of your time

• Have experience in aseptic CMO auditing

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.

• GMP Auditor: 2+ years

• 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.


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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.
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