Regeneron is currently looking for a Sr. Manager with for our Drug Product Manufacturing Sciences and Technology (MSAT) compliance team. The compliance team leads and supports all Process Sciences Drug Product Engineering (PSDPE) quality results. Leads or support activities associated with internal audits, deviation investigations, change controls, and CAPAs associated with Regeneron’s External DP Manufacturing network. The Sr. Manager will establish standard methodologies in all quality and compliance related activities, define and lead key quality metrics, and aid with ensuring we are audit ready and remain aligned with cGMP practices, departmental Standard Operation Procedures (SOPs) and policies.
As a Sr. Manager DP MSAT , a typical day might include the following:
- Leads and prioritizes operations and practices for deviation investigations, CAPAs and Change Controls for clinical and commercial External Manufacturing (EM).
- Develop, trains, and coaches reports to lead investigations to identify practical root causes and robust corrective and preventative actions by optimally applying sophisticated root cause analysis tools
- Supports audit closure of new and existing external manufacturing partners.
- Collaborates with multi-functional teams to effectively address observations and drive CAPAs to completion
- Provides expertise to the global organization on cGMP compliance, standard methodologies as well as new and developing cGMP regulatory requirements and trends
- Responsible for generating, tracking, and improving compliance activities
- Guides and supports the sites in devising and implementing remediation actions to ensure compliance to regulatory and Regeneron’s expectations and requirements
- Supports analysis of regulatory observations made at Regeneron’s EM sites, prepares, and coordinates the global follow-up/gap analysis to prevent re-occurrence
- Aid with the maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at External Manufacturing contract manufacturers
- As needed, travels to contract manufacturers or business partners to support compliance related topics
This role might be for you if:
- You enjoy QA and compliance work
- Experience interacting with Contract Manufacturing Organizations
- Proven technical expertise in drug product manufacturing and/or product development and validation
- Demonstrated proactive approach to issue resolution with an ability to work well across various departments as well as business partners
- Excellent interpersonal, cross-cultural, communication, teamwork, 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.)
To be considered for Sr. Manager you must have a BS/BA in engineering or scientific related field. For various levels you must have the following:
- Sr. Manager DP MSAT: 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
Level is determined based on qualifications relevant to the role.
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 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.