Associate Director GCP Quality

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:

The Regeneron GCP Quality Improvement Manager will work with GCP Quality Improvement team to ensure that Regeneron Global Clinical Development Processes and Procedures are followed, and that any Process Deviations are investigated and documented with the Quality Management System. The GCP Quality Improvement Manager will also manage Corrective or Preventive Actions (CAPA) within the Quality Management System. They will partner with other members of the GCP Quality group to identify trends through metrics in order to diagnose and remediate systemic quality issues, and will serve as a core member of Continuous Improvement initiatives.

Duties:

• Liaise with GCP Compliance & Process Teams to proactively identify opportunities to streamline and strengthen GCP process
• Serves as GCP SME when SOPs are written or revised
• Manage Quality Events and Actions (Process Deviations, CAPA) within a regulated Quality Management System
• Represent GCP expertise on cross-functional teams for GCP related process improvements resulting from new/revised regulations or guidance
• Leads cross-functional rapid response teams for identified GCP process violations needing immediate remediation.
• Work closely with Regulatory Intelligence team to identify changes in global regulations affecting current Regeneron processes as they relate to GCP
• Interfaces: SOP & Process team; GCP Inspection teams; functional process owners, and CPMO Process improvement leads
• Committees: standing members of GCP Quality Forum & SSN Committee

Requirements:

• Bachelor's degree ( Master's degree preferred) with 5-7 years of relevant industry experience (Level commensurate with experience)

• >5 years' experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.

• Demonstrated experience and leadership on Continuous Improvement or Quality Improvement efforts (GCP Quality Improvement preferred)

• Demonstrated Quality Management System experience (GCP specific QMS experience preferred)

• Demonstrated Issue Management and CAPA experience in a clinical environment

• Excellent communication skills and ability to work with people in all levels of the organization and externally.

• Demonstrated skills in taking initiative and working independently

• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.

• Self-motivated with the ability to work effectively in a dynamic environment

• Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization

• Good problem solving, written and verbal communication skills

• Ability to effectively manage multiple priorities with a sense of urgency

• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations

• Attention to detail and accuracy of work

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.