Compliance Manager (Technical Operations)

Within this role you will be responsible for providing oversight for all aspects of cGMP compliance for Technical Operations.

As a Compliance Manager (Technical Operations), a typical day might include, but is not limited to, the following:

• Evaluating Technical Operations, Engineering and/or Automation department systems and processes for adherence to cGMPs and industry best practices, and implement changes/improvements as needed global

• Being responsible for on-boarding and setting priorities for direct reports within the department. Manages area through direct reports which may include Associate Managers and Managers with direct reports

• Leading audit readiness program and maintains regulatory requirements for Automation, Engineering and Technical Operations

• Interfacing regularly with Quality Assurance, Manufacturing and other departments or functional areas to facilitate decisions pertaining to quality system deliverables

• Taking responsibility for specifying and coordinating training, development, and compliance for Technical Operations, Automation, and/or Engineering Compliance personnel, including consultants

• Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations

• Acting as a liaison to Quality and Regulatory groups for Technical Operations, Automation, and/or Engineering departments to address potential compliance issues

• Providing primary support for all regulatory and partner audits and inspections

• Developing, tracking, trending, and maintaining Technical Operations, Automation, and/or Engineering department metrics for presentation to site leadership. Including, but not limited to: Audit readiness, PM's and/or PERs

• Leading development and review of departmental policies, Standard Operating Procedures, Work Instructions, Job Aids, System Design Specifications, and Equipment Specifications

• Providing support and assistance to department members for the initiation, review, submission, and administration of documents. Including, but not limited to; Impact Assessments, PMs and/or PERs

• Overseeing and administering Periodic Evaluation Reporting program for all automation systems

• Maintaining company reputation by enforcing compliance with FDA/EU regulations and any other applicable agency as required

This role may be for you if: 

• You show solid leadership and project management skills with demonstrated track record of effective supervision of technical personnel

• You have a thorough ability to coach others on effective problem solving

• You possess excellent interpersonal, written, and oral communication skills

• You have a strong knowledge of cGMPs, GxP, CFR, Quality Systems, and/or other regulatory requirements

• You demonstrate the ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity

• You exhibit strong knowledge of word processing, spreadsheets, PowerPoint database management software, and PCs

To be considered for this opportunity you should have a BS/BA in an engineering or scientific related field with 7+ years of related experience or an equivalent combination of education and experience. Preferred experience in working in a CGMP or regulated environment along with experience in a leadership role.

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.