Director QA Inspection Management

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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

This position is an integral part of the team that manages inspections through the prep, performance and follow-up of items requested by international regulatory agencies and partner audits. This position directs and manages cross-functional teams in inspection readiness, ongoing inspections, and inspection follow-up for GCP/GPV/GLP inspections by global regulatory authorities. This postion performs inspection readiness visits at global clinical sites. The individual works with functional leaders to build inspection readiness capabilities across the organization at non-manufacturing facilities.

Job Duties:

• Directs and manages inspection responses, commitments, post-inspection activities, corrective and preventative actions, resolving conflicts for timely closure.

• During onsite inspections, acts as inspection host or leads ready room activities.

• Manages direct reports

• Supports and leads teams implementing best practices and improvements to assure teams are inspection ready at all times.

• Develops tools to improve inspection management process; determine system improvements.

• Directs and manages cross-facility (Tarrytown, Baskingridge, Dublin, Uxbridge) and cross-GxP inspection activities.

• Develops and manages inspection metrics and reports trends senior personnel when necessary.

• Performs inspection readiness visits at clinical sites in support of potential regulatory agency inspections

• Collaborates with cross-functional teams responding to incoming inquires during inspections and audits and ensure timely and accurate responses.

• Provides advice and direction to company departments on quality and inspection related issues

Requirements:

List the minimum qualifications required to successfully perform the job

• 8+ years of regulatory inspection experience in GxP, GCP preferred

• 5+ years management experience preferred

• Knowledge and experience preparing and conducting regulatory authority inspections with GCP, GLP, and GPV preferred

• Direct interaction with inspectors preferred

• Knowledge and understanding of global GxP regulations with emphasis on GCP and ICH

• Knowledge of clinical development, pharmacovigilance, laboratory practices

• Self-motivated, hard-working, achievement-oriented with the ability to work effectively in a dynamic environment

• Demonstrated ability to interface with senior leaders and cross-functional teams

• Good problem solving, written and verbal communication skills

• Demonstrated ability to effectively manage multiple priorities with a sense of urgency

• Attention to detail and accuracy of work
15+ years. Degree plus 8+ years of relevant inspection experience or 15+ years with no degree where 8+ is preferred with relevant inspection experience. Practical experience with inspections is critical and a degree doesn't supply that experience.

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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.