Director, Sterile and Microbiology Quality Assurance Job - Germany
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MSD is a global health care leader with a
diversified portfolio of prescription medicines, vaccines and animal health
products. The difference between potential and achievement lies in the spark
that fuels innovation and inventiveness; this is the space where MSD has codified
its 125-year legacy. MSD’s success is backed by ethical integrity, forward
momentum, and an inspiring mission to achieve new milestones in global
Director, Sterile & Microbiology Quality Assurance is responsible for
providing leadership and direction for microbiology testing, Microbiology
Laboratory, and related topics in sterile, non-sterile, biologic manufacturing
for assigned topics. Leads the development, deployment and maintenance of
multiple divisional quality standards or SOP to ensure MMD is compliant to
cGMPs for these topics. Serves as the Sterile and Microbiology QA point
of contact for multiple sites in the MMD network. Leads divisional
projects across internal and/or external sites.
the Sterile and Microbiology QA lead for specific topics, is responsible for
the regulatory requirements and cGMP expectations.
authoring, and maintaining the divisional quality standards in alignment with
regulatory requirements and cGMP expectations.
and ensuring consistency in sites meeting the standards for the topic (e.g.
providing training, supporting gap assessments, reviewing remediation plans and
metrics for MMD network sites to meet the divisional standards, where
and tracking quality metrics to transform performance at MMD network sites, where
support to CMC when questions arise from regulators during review of filings.
and facilitating compliance related communities of practice
MSD in external forums, conferences, and working groups such as ISPE, PDA,
PhRMA, or USP.
the Sterile and Microbiology point of contact for a manufacturing area or
microbiology lab, is responsible for
the compliance gaps and quality improvement goals for microbiology topics.
global microbiology team support for prioritized topics.
with the sites and regional QO to ensure consistency and alignment to
cross functional teams to
the compliance and/or quality for microbiology topics in the manufacturing
areas, laboratories, or interfacing with Research.
of maintain a collection of Quality Standards
and/or influence regulatory or industry standards
expert support to sites related regulatory inspections, development of
responses to inspection observations, significant investigations, and guidance
regarding corrective actions
M.S. and/or Ph.D. preferably in Science or Engineering such as
Microbiology, Biochemical Engineering
Experience and Skills:
minimum of 10 years’ experience in the pharmaceutical, biopharmaceutical,
vaccine, or medical device industry.
knowledge of EMEA, MHRA, and FDA regulations
- Experienced with USP, EP, and BP and
ISP industry standards
knowledge of Microbiological Laboratory & Microbiology Testing
experienced in regulatory inspection and responses.
experienced in listening to and gathering a range of perspectives and with
ability to develop solutions and champion a position.
written and oral communicator
Experience and Skills:
knowledge of three or more microbiology topics related to sterile,
non-sterile, or biologic processing and/or microbiology methods
knowledge of international GMPs and Quality Management requirements of
various regulatory agencies that may include US FDA, EMEA, TGA, HPB,
ANVISA, COFEPRIS, ANMAT, KFDA and PMDA.
of worldwide compendia and ISO industry standards.
experience working as part of a regulatory agency or on USP Microbiology
Expert Committee or equivalent
tolerance for ambiguity.
and relates well with the shop floor and laboratory technicians .
Your role at MSD is integral to helping the world meet
new breakthroughs that affect generations to come, and we’re counting on your
skills and inventiveness to help make meaningful contributions to global
medical advancement. At MSD, we’re inventing for life.
Job: Qual Assurance & Ops Generic Job Title:Dir, Quality Assurance
Primary Location: EMEA-Germany-BE-Berlin
Other Locations: Europe, Middle East & Africa
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
External Job Board Posting: Switzerland - Jobs.ch
Company Trade Name:MSD
Job Segment: Biochemistry, Microbiology, Medical, Medical Technologist, Manager, Science, Healthcare, Management