Associate Manager, Facilities Compliance

Location
Rensselaer, New York, United States of America
Posted
Jul 16, 2021
Ref
25244BR
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill an Associate Manager, Facilities Compliance position. This position is responsible for leading all aspects of a team of Facilities Compliance Specialists that handle 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.

In this role, a typical day might include the following:
  • Supervise progress on all Facilities quality system items, 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 and to help facilitate critical decisions pertaining to quality system results
  • Supervise, report, and respond to Key Performance Indicators for the compliance functions, e.g. right-first-time for deviation investigations
  • Review work record documentation for completeness, accuracy and compliance, and provide mentorship 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
  • Collaborate 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 standard methodologies, and implement changes/improvements
  • Represent the Facilities department on various topics during regulatory inspections, and coordinate responses to inspection observations
  • Support the start-up/integration of Facilities compliance functions at other sites, including travel


This role might be for you if you have:
  • Excellent written, verbal and interpersonal communication skills and the ability to work with all levels to communicate negative information and offer solutions
  • Ability to effectively interact with regulatory inspectors
  • Attention to detail and investigational, problem solving and interpersonal skills
  • Ability to balance multiple projects and changing priorities with organizational skills
  • A positive, proactive approach to drive projects/tasks to completion

To be considered for this role you must hold a Bachelor's degree in Engineering or Life Sciences subject area, 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. Equivalent combination of education and experience may be considered.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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