BrightOwl Loader Loading

Director, Sterile and Microbiology Quality Assurance Job - Germany  

Company managed [?] Still accepting applications

Posted on : 22 April 2017

Project Description

Director, Sterile and Microbiology Quality Assurance-QUA005810

Description

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
healthcare.

The
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.

1. As
the Sterile and Microbiology QA lead for specific topics, is responsible for

a) Identifying
the regulatory requirements and cGMP expectations.

b) Developing,
authoring, and maintaining the divisional quality standards in alignment with
regulatory requirements and cGMP expectations.

c) Deploying
and ensuring consistency in sites meeting the standards for the topic (e.g.
providing training, supporting gap assessments, reviewing remediation plans and
variances).

d) Tracking
metrics for MMD network sites to meet the divisional standards, where
applicable.

e) Defining
and tracking quality metrics to transform performance at MMD network sites, where
applicable.

f) Providing
support to CMC when questions arise from regulators during review of filings.

g) Organizing
and facilitating compliance related communities of practice

h) Representing
MSD in external forums, conferences, and working groups such as ISPE, PDA,
PhRMA, or USP.

2. As
the Sterile and Microbiology point of contact for a manufacturing area or
microbiology lab, is responsible for

a) Understanding
the compliance gaps and quality improvement goals for microbiology topics.

b) Coordinating
global microbiology team support for prioritized topics.

c) Working
with the sites and regional QO to ensure consistency and alignment to
microbiology topics.

3. Leads
cross functional teams to

a) Transform
the compliance and/or quality for microbiology topics in the manufacturing
areas, laboratories, or interfacing with Research.

b) Develop
of maintain a collection of Quality Standards

c) Understand
and/or influence regulatory or industry standards

Provides
expert support to sites related regulatory inspections, development of
responses to inspection observations, significant investigations, and guidance
regarding corrective actions

Qualifications

- B.S.,
M.S. and/or Ph.D. preferably in Science or Engineering such as
Microbiology, Biochemical Engineering

Required
Experience and Skills:

- A
minimum of 10 years’ experience in the pharmaceutical, biopharmaceutical,
vaccine, or medical device industry.

- Expert
knowledge of EMEA, MHRA, and FDA regulations

- Experienced with USP, EP, and BP and
ISP industry standards

- Expert
knowledge of Microbiological Laboratory & Microbiology Testing

- Highly
experienced in regulatory inspection and responses.

- Highly
experienced in listening to and gathering a range of perspectives and with
ability to develop solutions and champion a position.

- Excellent
written and oral communicator

Preferred
Experience and Skills:

- Advanced
degree desirable.

- Expert
knowledge of three or more microbiology topics related to sterile,
non-sterile, or biologic processing and/or microbiology methods

- Expert
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.

- Knowledge
of worldwide compendia and ISO industry standards.

- Direct
experience working as part of a regulatory agency or on USP Microbiology
Expert Committee or equivalent

- Demonstrates
tolerance for ambiguity.

- Good
teacher

- Hands-on
and relates well with the shop floor and laboratory technicians .

- Quality
Risk Management

- Change
Execution Management
- Project
Management

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