Manager GMP Compliance and Inspections
About this role
We are seeking a Manager
for
GMP Compliance & Inspections who will
work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron.
This individual will play a leading role in the preparation and execution
of regulatory
inspections, partner
audits
and internal audits, as well as follow up post audit/inspection on any items requiring response and
action.
This
role will also promote and drive compliance by building inspection readiness processes across the organization.
As the Manager GMP Compliance & Inspections a typical day might include the following:
Ensuring readiness for
regulatory inspections and partner
/other
audits in the creation,
maintenance
and management of inspection content, ensuring it is organized, current and readily accessible
at all times
P
lanning
all inspection and audit
logistics
and scenarios
:
communication
plan,
room allocations, backroom/
frontroom
configuration, technology checks &
personnel
assignments
Performing
a lead role in the audit/inspection Backroom
and r
esponding to incoming
requests
during inspections and audits and ensuring
timely
and
accurate
responses
Evaluating outcomes of regulatory authority inspections/partner and other audits to
identify
near misses, lessons learned and other best practices and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented
Coordinating inspection/audit responses and
actively
managing
commitments to regulatory authorities/audit bodies in response to inspection/audit findings
Working collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA
tracking, and
confirming their
timely
closure and ensuring suitable effectiveness checks are in place
M
aintaining
and enhancing
communication process
es
to site management on the status of regulatory
inspection
readiness and CAPA commitments
, including development of
appropriate KPI
s
Generating,
developing
and reporting metrics / trends for program adherence to requirements and effectiveness
Participating in
proactive evaluation and education of site GMP compliance against current and emerging regulatory trends
Utilising
strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership
with regard to
complex problems
Supporting and leading teams implementing practices and improvements to
make IOPS inspection-ready at all times
Building and implementing tools to improve IOPS inspection readiness;
determining
system improvements through effective project management
Developing and delivering training on inspection conduct, backroom/
frontroom
protocols, and regulatory expectations
Working with department leaders and cross functional teams to educate, building and
maintaining
an
inspection
readiness structure across the organization
Liaising with partners on audit/inspection and quality related matters to provide guidance and advice
Participating
on
internal committees/teams, as
Requirements
- Cross-site support
- of
- inspection readiness and inspection activities
- Coordinating Regeneron information to support regulatory requests for paper inspections and/or observation responses
- Additional
- duties may be assigned as
- .
- This role might be for you if:
- You have strong project management, interpersonal, cross- cultural, communication, negotiation, and problem-solving skills
- You understand and listen to team members and stakeholders while fostering a productive team environment to one common objective
- You are driven for proactive resolution of issues with tact, diplomacy and composure
- You show resiliency and flexibility in the face of challenges and adversarial situations
- You are able to provide clear direction to others in ambiguous situations and environments
- You possess knowledge of industry practices and regulations
- To be considered for this role you should have a
- BA/BS degree in
- L
- ife S
- cience
- s and the following minimum years of relevant experience for each level:
- Assoc
- Manager
- :
- 6+ years of relevant experience, preferably in the pharmaceutical or biotech industries
- or related field or equivalent combination of education and experience.
- Manager
- :
- 7+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.
- Level will be determined based on qualifications and experience relevant to the role.
- #IRELIM #JOBSIEST #LI-Onsite
- Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
- Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
- 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.