Associate Manager Manufacturing Compliance (Change Control)

Regeneron Pharmaceuticals • Rensselaer, NY • 1w ago

We are currently looking to fill an Associate Manager, Manufacturing Compliance (Change Control) position with a 1st shift Monday-Friday, 8:00am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Manager, Manufacturing Compliance (Change Control) leads a team with direct oversight of work for deviations, corrective actions, and all associated change controls.

This position will be open for applicants until COB 02Jun2025.

As Associate Manager, Manufacturing Compliance (Change Control), a typical day might include the following:

Designs business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPA's) and process improvements in support of manufacturing operations.

Reviewing, verifying and approving system records

Reviews, edits, and revises controlled documentation in accordance with cGMP standards.

Independently coordinates and/or leads cross-functional meetings with multiple departments to drive change control implementation.

Provides advice and guidance to cross-functional teams to enable successful and GMP compliant change controls.

Works cross-functionally to develop and propose streamlined implementation strategies for change controls of increased complexity.

Recommends corrective actions based on investigational findings.

Involved in post-production management of events as required to facilitate closures to meet the required timelines.

Presents business critical and regulatory impactful change controls to senior leadership and during regulatory inspections

Leads projects and participates in quality driven business initiatives.

Independently performs advanced troubleshooting to identify and implement solutions to obstacles encountered by their team during the change control process.

Tracks quality system metrics including deviations, corrective actions, change controls, and controlled document workflows.

Develops strategies to streamline the ways of working; uses metrics/data to present findings and recommendations to management.

Perform personnel management functions (i.e. annual employee evaluations, coaching, mentoring, training performance feedback, etc.).

This role might be for you if you:

Excel in a quality driven organization.

Can navigate changing priorities through robust organizational, planning, and people management skills.

Have a strong attention to detail.

Have strong technical writing, interpersonal communication, and presentation skills.

Can learn and utilize computerized systems for the performance of daily tasks.

Have experience navigating a controlled quality system

To be considered for this role you must hold a Bachelor's degree in Life Sciences or related field and the following minimum amounts of relevant experience for each level:

Supervisor - 5+ years

Associate Manager - 6+ years

Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.

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.

Salary Range (annually)

$77,600.00 - $148,400.00

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