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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Schedules, prepares, and conducts audits in support of GMP as directed.
Education and Experience:
* Assembles and coordinates the activities of the audit team.
* Conducts audits in accordance with Regeneron standard operating procedures and quality policies.
* Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
* Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
* Escalates any compliance issues.
* Communicates audit results to management and auditees through written audit reports.
* Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts.
* Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
* Drafts and issues periodic reports to site management as requested.
* Assists with training/orientation for new Quality Auditing staff.
* Supervises junior auditors.
***This position requires 40% travel***
* BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment preferred. Other relevant experience may be considered in lieu of degree.
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.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.