Associate Manager Facilities Compliance

Location
Rensselaer, New York
Posted
Mar 20, 2018
Ref
12308BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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 a team of Facilities Compliance Specialists that manage deviation investigations, implementation of CAPAs, support of regulatory inspections, review of maintenance work records, SOP writing, and change control facilitation as well as other compliance tasks/functions.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Track progress on all Facilities quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates.
• Interface regularly with Quality Assurance, Manufacturing and other functional areas in order to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.
• Monitor, report, and respond to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations.
• Review work record documentation for completeness, accuracy and compliance, and provide feedback to Facilities technicians and other internal customers to ensure timely resolution of issues.
• Perform deviation investigations and coordinate CAPA implementation as needed for high risk events.
• Review departmental trend reports across numerous different Facilities functions as needed, e.g. quarterly review of corrective work records, pest control reports, critical utilities trending, etc.
• Interface with training specialists regularly to mitigate any compliance risks associated with the Facilities training program.
• Continually reassess Facilities systems and processes for adherence to cGMPs and industry best practices, and implement changes/improvements as needed.
• Represent the Facilities department on various topics during regulatory inspections, and coordinate responses to inspection observations as applicable.
• Support the start-up/integration of Facilities compliance functions at other IOPS sites, including travel as needed.
Education and Experience:
• Requires BS in an Engineering or Life Sciences discipline with a minimum of 6 years of experience in a compliance role within the pharmaceutical industry, including 2-3 years of experience in a leadership or project management role.
• Relevant experience will be considered in lieu of the educational requirement.

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.

Requisition Number: 12308BR