Director, Sterile & Microbiology Quality Assurance
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
TheDirector, Sterile & Microbiology Quality Assurance is responsible forproviding leadership and direction for the sterile standards associated withmanufacturing sterile drug substance and sterile drug product. Leads the development, deployment andmaintenance of multiple divisional quality standards or SOP to ensure MMD iscompliant to cGMPs for these topics. Serves as the Sterile and Microbiology QA point of contact formultiple sites in the MMD network. Leads divisional projects across internal and/or external sites.
As the Sterile and Microbiology QA lead for specifictopics, is responsible for:
- Identifying the regulatory requirements and cGMPexpectations.
- Developing, authoring, and maintaining the divisionalquality standards in alignment with regulatory requirements and cGMPexpectations.
- Deploying and ensuring consistency in sites meeting thestandards for the topic (e.g. providing training, supporting gap assessments,reviewing remediation plans and variances).
- Tracking metrics for MMD network sites to meet thedivisional standards, where applicable.
- Defining and tracking quality metrics to transformperformance at MMD network sites, where applicable.
- Providing support to CMC when questions arise fromregulators during review of filings.
- Organizing and facilitating compliance relatedcommunities of practice
- Representing Merck in external forums, conferences, andworking groups such as ISPE, PDA, PhRMA, or USP.
- Understanding the compliance gaps and qualityimprovement goals for microbiology topics.
- Coordinating global microbiology team support forprioritized topics.
- Working with the sites and regional QO to ensureconsistency and alignment to microbiology topics.
- Transform the compliance and/or quality formicrobiology topics in the manufacturing areas or interfacing with Research.
- Develop of maintain a collection of Quality Standards
- Understand and/or influence regulatory or industrystandards
- B.S., M.S. and/or Ph.D. preferably in Science or Engineering such as Microbiology, Biochemical Engineering
- 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 JP industry standards
- Expert knowledge of Sterile Processing, Microbiology Laboratory & Testing, and/or microbiology topics for non-sterile or bioburden reduced products.
- 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
- Expert knowledge of sterile processing, e.g. Annex 1
- 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 well with the shop floor and/or laboroatory technicans .
- Quality Risk Management
- Change Execution Management
- Project Management
Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck