Associate Director, Quality Auditing - Tarrytown, NY | Biospace
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Associate Director, Quality Auditing

Regeneron Pharmaceuticals, Inc.

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Location:
Tarrytown, NY
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
6738BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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: A high profile position in a rapidly growing biopharmaceutical company responsible for providing leadership and functional oversight for Quality Auditing of the Pharmacovigilance (PV) program. The incumbent will need to have the ability to identify compliance issues, manage relationships and execute resolution in a highly autonomous manner. This individual will provide strategic Quality input to PV leadership and support tactical implementation of PV improvements and projects. In addition, this individual will work closely with the PV team to develop processes and systems that drive compliance to critical regulatory requirements and be actively involved during inspections and inspection readiness activities.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Maintain professional expertise and knowledge of company policies and international regulations relative to Good Pharmacovigilance Practices (GVP) and Quality;
  • Collaborate with PV organization to ensure understanding and acceptance of the roles and responsibilities as well as ensure acceptance of all quality processes and procedures;
  • Provide guidance and direction on PV Quality matters;
  • Develop and execute strategic audit plans for PV activities including internal processes, service providers, vendors and collaboration partners;
  • Ensure visibility to PV and IOPS management of any noted deviations or deficiencies or quality signals/trends for improvement;
  • Participate within cross-functional team to implement an effective CAPA system for PV program and ensure timely closure of CAPAs;
  • Participate in Inspection readiness and Inspections as assigned;
  • Promote a GxP and Quality mindset at all levels;
  • Ensure that all quality based deliverables are complying with regulatory and quality policies and procedures, timelines are met and observations are corrected;
  • Ensure that all the appropriate PV Audit SOPs are in place and that the appropriate level of training and comprehension is achieved at all times;
  • Manages staff as assigned to work with project teams on their quality deliverables;
  • Coaches, develops and mentors Quality employees;
  • Ensures safety and operational standards are maintained.


Supervisory Responsibilities may include the following:

  • Senior Manager/Manager, PV Quality Auditing
  • PV Auditor; Sr. PV Auditor
  • Project Manager

BS/BA or higher in life sciences; CQE not required, but a plus.


Requirements

Knowledge and Skills:

  • Expertise in GVP/GCP quality systems;
  • Thorough knowledge of GxP requirements and international laws/regulations governing management of PV;
  • Solid team player able to function within a fast-paced culture;
  • Substantial experience presenting, interacting, and building effective relationships with representatives from regulatory agencies;
  • Excellent communication and presentation skills (articulate and persuasive);
  • Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with internal and external professionals;
  • Teaches and coaches others in technical and leadership areas;
  • Strong decision-making abilities;
  • Self-directed and ability to take action with limited oversight;
  • Disciplined, detail-oriented and strong time management skills;
  • Working knowledge of word processing, spreadsheet, database management statistical analysis, graphing, presentation, and scheduling software.


Education and Experience:

  • Minimum BS in life sciences;
  • A minimum of 10 years experience in the pharmaceutical/biotechnology industry (biotech preferred) and PV/auditing;
  • A minimum of 5 years in a managerial capacity.

Equipment:
Computer and general office equipment.

Business Contacts:
Internal:
Director or VP level in CDRA-PV and IOPS; Corporate peers.

External:
Outside vendors, service providers, regulatory agencies, collaboration partners, clinical trial sites.

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.