Associate Manager, Facilities Compliance

We are currently looking to fill an Associate Manager, Facilities Compliance position. This position is responsible for supervising a team of Facilities Compliance Specialists that support 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:

• Support progress of 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 issues, 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 guidance to Facilities technicians and other internal customers to ensure timely resolution of issues

• 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 effectively interact 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 prioritize multiple projects and changing priorities with organizational and time management 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 field, 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.