Director, GMP Inspection Management
Company: Regeneron Pharmaceuticals, Inc
Location: New York
Posted on: November 13, 2024
Job Description:
We are currently looking to fill a Director of GMP Compliance &
Inspections position. This position will work with cross-functional
teams to drive activities that will ensure a state of continuous
GMP compliance in Regeneron IOPS and to build inspection readiness
capability across the organization. This role will help to build
mechanisms within the business to educate on compliance awareness
and ensure we are performing within compliance. The Director will
also provide support during regulatory inspections and internal
audits and work to ensure that all identified content is organized,
current and readily accessible in the event of an inspection or
audit purposes.In this role, a typical day might include the
following:
- Apply strong critical thinking skills to serve as a thought
partner to the GMP Compliance and Inspections leadership with
regard to sophisticated problems.
- Lead proactive evaluation and education of site GMP compliance
against current and emerging regulatory trends.
- Define and implement systems, and metrics for maintaining
regulatory compliance all operations.
- Perform evaluations of GMP compliance across all areas of the
site as well as procedures and processes.
- Collaborate with customer/partner quality organizations.
- Participate on internal committees/teams, as required.
- Provide advice and direction to other departments on quality
and regulatory issues.
- Inspection Readiness
- Benchmark leading practices and recommend improvements to make
IOPS inspection-ready at all times.
- Maintain inspection readiness content, including building and
maintaining a content repository, to ensure quick access to
materials in the event of inspection or audit.
- Build and implement tools to improve IOPS inspection
readiness.
- Identify trends in recent regulatory inspections and translate
this to recommendations to improve readiness.
- Work closely with other regulatory compliance teams to close
gaps and improve inspection readiness capabilities.
- Inspection Execution
- Liaison with regulatory bodies and partners on audit,
regulatory, and quality related matters. Will also provide advice
to partners and internal associates on regulatory and quality
matters.
- Respond to incoming inquiries during inspections and audits and
ensure timely and accurate responses during audit.
- Coordinate responses to regulatory or partner audits.This role
may be for you if you:
- Are knowledgeable in industry practices and regulations (cGMP,
Annex I) and across multiple health authorities (e.g. FDA, EMA,
MHRA, etc.)
- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operationsTo
be considered for this role you must hold a Bachelor's degree in
chemical engineering/chemistry/life sciences and the following
amount of related experience, preferably in the pharmaceutical or
biotech industries or related field, for each level:
- Associate Director - 10+ years
- Director - 12+ yearsMay substitute proven experience for
education requirement. Level is determined based on qualifications
relevant to the role.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)$142,700.00 - $277,100.00
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Keywords: Regeneron Pharmaceuticals, Inc, Danbury , Director, GMP Inspection Management, Executive , New York, Connecticut
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