Associate Director, Sterile & Microbiology QA 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.
Associate Director, Sterile and Microbiology Quality Assurance, is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic Manufacturing, and/or Microbiology Laboratories in 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. Responsibilities include:
- As the Sterile and Microbiology QA lead for specific topics, is responsible for
- Identifying the regulatory requirements and cGMP expectations.
- Developing, authoring, and maintaining the divisional quality standards in alignment with regulatory requirements and cGMP expectations.
- Developing change control package for divisional microbiology analytical standards
- Deploying and ensuring consistency in sites meeting the standards for the topic (e.g. providing training, supporting gap assessments, reviewing remediation plans and variances).
- Tracking metrics for MMD network sites to meet the divisional standards, where applicable.
- Defining and tracking quality metrics to transform performance at MMD network sites, where applicable.
- Providing support to CMC when questions arise from regulators during review of filings.
- Organizing and facilitating compliance related communities of practice
- Representing Merck in external forums, conferences, and working groups such as ISPE, PDA, PhRMA, or USP.
- As the Sterile and Microbiology point of contact for a manufacturing area or microbiology lab, is responsible for
- Understanding the compliance gaps and quality improvement goals for microbiology topics.
- Coordinating global microbiology team support for prioritized topics.
- Working with the sites and regional Quality organizations to ensure consistency and alignment to microbiology topics.
- Provides expert support to sites related regulatory inspections, development of responses to inspection observations, significant investigations, and guidance regarding corrective actions.
- Co-ordinate regional input into draft policies, procedures and guidelines. Author and/or review technical reports/position papers.
- Bachelor degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering or related science discipline.
- Minimum 10 years experience in sterile pharmaceutical industry.
- Experience with EU and/or FDA regulations.
- Broad experienced in microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods.
- Experience in transforming GMP compliance.
- Excellent spoken and written English.
- Demonstrated ability to effectively work hands-on with shop floor personnel.
- Ability to travel 30 to 50% of the time.
- 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 USP and EU compendia and ISO industry standards.
- Good teacher
- Quality Risk 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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Job: Qual Assurance & Ops Generic
Job Title:Assoc. Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-North Carolina, NA-US-New Jersey, NA-US-Virginia
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Microbiology, Medical Technologist, Medical, Law, Pharmaceutical, Science, Healthcare, Legal