Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Responsible for planning and conducting quality audits in assigned areas in preclinical (GLP), within designated Quality Auditing areas.
Essential Duties and Responsibilities include, but are not limited to, the following:
- May schedule, prepare and conduct audits in support of GLP as directed.
- May assemble and coordinate the activities of the audit team.
- Conducts audits in accordance with Regeneron standard operating procedures and quality policies.
- Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.
- Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
- Appropriately escalate any compliance issues.
- Communicates audit results to management and auditees through written audit reports.
- May manage post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
- May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
- May assist with training/orientation of new Quality Assurance staff.
Education and Experience:
- 5+ years of related experience in Biotech/Pharmaceutical industry, to include 2-5 years of direct audit experience in a core area GLP for ‘Auditor’ consideration. 5-8 years of direct audit experience in one or more core area GLP for ‘Sr. Auditor’ consideration.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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