Director, Sterile and Microbiology Quality Assurance Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 Merck 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
- 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 experience in regulatory inspection and responses.
- Highly experience 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
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Qual Assurance & Ops Generic
Job Title:Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth, NA-US-VA-Elkton, NA-US-NC-Durham
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Manager, Medical, Medical Technologist, Microbiology, Biochemistry, Management, Healthcare, Science