Manager Drug Product- Compliance
Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: January 20, 2023
Job Description:
Regeneron is currently looking for a Manager 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 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 topicsThis 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 the Manager you must have a BS/BA in
engineering or scientific related field. For various levels you
must have the following:
- Associate Manager DP MSAT: BS/BA in engineering or scientific
related field and 6+ of experience; or equivalent combination of
education and experience
- Manager DP MSAT: BS/BA in engineering or scientific related
field and 7+ of experience; or equivalent combination of education
and experience
- Sr. Manager DP MSAT: BS/BA in engineering or scientific related
field and 8+ of experience; or equivalent combination of education
and experienceExperience working in a cGMP environment or aseptic
parenteral filling suite is preferred. 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 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) $85,800.00 - $180,500.00
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Manager Drug Product- Compliance, Executive , Troy, New York
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