Associate Manager/Manager, GCP Quality Auditing - Rensselaer, NY | Biospace
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Associate Manager/Manager, GCP Quality Auditing

Regeneron Pharmaceuticals, Inc.

Rensselaer, NY
Posted Date:
Position Type:
Full time
Job Code:
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, 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: Responsible for overseeing and managing direct reports and their assignments within designated Quality Assurance & Auditing Good Clinical Practice (GCP) area, as well as planning and conducting GCP audits.

*Manages and leads staff to accomplish the annual audit schedules in assigned area(s).
*Provide leadership, guidance, and supervision to direct reports and other staff as required.
*Assesses and prioritizes both internal and external audit needs, in consultation with relevant management of Procurement, QA, Global Clinical Development, and Regulatory.
*Conducts audits and performs duties in accordance with Regeneron standard operating procedures and quality policies.
*Present findings and metrics at departmental and interdepartmental meetings and shares quality issues, as required.
*Trains and on-boards new QAA staff and is responsible to ensure all direct reports are appropriately trained.
*Becomes involved as required to meet established deadlines or resolve problems.
*Identifies training opportunities for current staff and facilitates training.
*Responsible for the training and oversight of contract auditors, within their respective functional area.
*Drafts and issues periodic reports to management.
*Applies complete functional knowledge and awareness of company goals and objectives.
*Manages QAA functional area standard operating procedures.
*Supports regulatory inspections and inspection readiness activities for Regeneron and partner organizations.
*Provides quality assurance support to customer groups (e.g., Global Clinical Development & Regulatory Affairs) to help ensure compliance with regulations and Regeneron procedures.


Education & Experience:
*BS/BA in Life Sciences or related field (may substitute relevant experience in lieu of educational requirement).
*5-8 years of relevant clinical (GCP) experience and at least 1 year (3+ years for Mgr) of supervisory or leadership experience. May substitute additional years of experience in lieu of supervisory 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.