Manager External Manufacturing Compliance

We are currently looking to fill a Manager of External Manufacturing (EM) Compliance position. This role helps coordinate compliance items through Regeneron Quality Systems. This includes Change Control, CAPA and Suppler Corrective Action Request records in relation to leading production at CMOs and other vendors that the External Manufacturing function oversees. The Manager will establish standard processes in all compliance related activities, define and lead key metrics and manage EM cGMP policies and SOPs.

In this role, a typical day might include the following:

• Leads and manages a team that provides compliance related support for the External Manufacturing Functions.

• Advises a team as counterparts to External Manufacturing Operations, build positive relationships with counterparts and peers.

• Collaborates across teams.

• Owns and manages compliance items through Regeneron Quality Systems.

• Prioritizes operations and establish standard methodologies for leading Change Control, CAPA, and Supplier Corrective Action Requests for clinical and commercial External Manufacturing.

• Supports Regulatory inspections and internal audits.

• Develops, trains, mentors and coaches EM specialists on compliance related items.

• Provides expertise to the global EM organization on cGMP compliance, standard processes as well as new and developing cGMP regulatory requirements and trends.

• Reviews and maintains procedures, polices and other instructional documents.

• facilitate continuous improvement initiatives specific to the work responsibilities of team.

• Prepares and presents performance metrics to management.

• Identify and implement continuous improvement initiatives.

• Provides advice and support to external sites during regulatory inspections and customer audits as requested by EM Leadership Team.

• Supports regular analysis of regulatory observations made at Regenerons EM sites, prepares and coordinates the global follow-up/gap analysis to prevent re-occurrence.

• Assists in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at External Manufacturing contract manufacturers.

• Travels less than 5% (domestic and international).

This role might be a fit for you if:

• You demonstrate a proactive approach to issue resolution with an ability to work well across various departments as well as business partners.

• Excellent interpersonal, cross-cultural, communication, collaboration, negotiation and problem-solving skills.

• Good knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.).

• Experience interacting with Contract Manufacturing Organizations a plus.

• Technical expertise in Bulk, Fill, and or Pack and Label manufacturing.

• Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).

• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills, qualification preferred.

To be considered for the Associate Manager level, you must have a BS/BA in engineering or scientific related field and 6 years of related professional experience in a cGMP environment or in the operation of an industrial facility, including 5 years of experience working in an aseptic parenteral filling operation cGMP environment, or equivalent combination of education and experience.

To be considered for the Manager level you must have a BS/BA in engineering or scientific related field and 7 years of related professional experience in a cGMP environment or in the operation of an industrial facility, including 5 years of experience working in an aseptic parenteral filling operation cGMP environment, or equivalent combination of education and experience.

To be considered for the Senior Manager level you must have a BS/BA in engineering or scientific related field and 8 years of related professional experience in a cGMP environment or in the operation of an industrial facility, including 5 years of experience working in an aseptic parenteral filling operation cGMP environment, or equivalent combination of education and experience.

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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$86,900.00 - $194,200.00