Associate Director, Quality Assurance & Auditing

Organization: 
Regeneron
Job Location: 
Tarrytown, NY
Job Description: 

If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

Summary:
A high profile position in a rapidly growing biopharmaceutical company responsible for providing leadership and functional oversight for Quality Assurance & Auditing of clinical and pharmacovigilance operations. Individual will serve as part of a FUN, DYNAMIC team in a fast-paced environment and will assist with overseeing the realization of industry best practices for GCP and PV while remaining adaptable to the changing needs of the company. Individual will work closely with the GCP and PV teams, assist with the develop processes and systems that drive compliance to critical regulatory requirements, and responsible for planning and conducting quality audits in assigned areas. This individual will need to have the ability to manage relationships, identify compliance issues and execute resolution in a highly autonomous manner.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Collaborate with Management to ensure understanding and acceptance of the roles and responsibilities of the Clinical and Pharmacovigilance organizations as well as ensure acceptance of all quality processes and procedures.
- Provide guidance and direction on Quality matters.
- Promotes a GXP and Quality mindset at all levels.
- Creates and maintains a strong relationship with the leadership team and participates in all appropriate meetings and venues.
- Work with the Clinical and Pharmacovigilance Management and Quality Management team to ensure continuity.
- Work with the Director of Quality Assurance & Auditing to ensure an appropriate strategy and execution for audits through defined processes and practices.
- Ensure visibility to and management of any noted deviations or deficiencies through trend and root cause analysis and works with the appropriate team and internal QA Staff to implement a CAPA system and processes.
- Fosters consistent Quality processes between the various divisions of clinical, pre-clinical and manufacturing.
- Ensures that all quality based deliverables are complying with regulatory and quality policies and procedures and timelines are met and observations are corrected.
- In collaboration with the Directory of Quality Assurance & Auditing, ensures that all the appropriate SOPs are in place and that the appropriate level of training and comprehensive has occurred.
- Manages staff as assigned to work with project teams on their quality deliverables.
- Ensures direct-report staff is appropriately resourced, supported and has the tools and direction to properly execute their function.
- Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into Regeneron systems.
- Coaches, develops and mentors direct reports.
- Ensures safety and operational standards are maintained.

Education and Experience:
- A minimum of 10+ years experience in the pharmaceutical/biotechnology industry (biotech preferred)
- A minimum of 10+ years in clinical and pharmacovigilance management/auditing.- Thorough knowledge of GxPs.
- Prior experience in a managerial capacity, as well as technical experience in a relevant operations function.
- BS/BA or higher in life sciences; CQE not required, but a plus

We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer:
Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com

ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

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