Director Sterile & Microbiological Quality Assurance

Job Description

Director, Microbiological Quality and Sterility Assurance (MQSA) is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic manufacturing, vaccine manufacturing and/or microbiology laboratories for assigned topics.

Primary activities include, but are not limited to:

• Leads the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our Manufacturing Division is compliant to cGMPs for these topics.
• Leads divisional projects across internal and external sites. 
• Leads team in development of strategy and assigning project and site support for MQSA.

Education Minimum Requirement and Experience:

• Bachelor of Science (BS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with ten (10) years’ experience in sterile pharmaceutical industry. OR
• Master of Science (MS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with eight (8) years’ experience in sterile pharmaceutical industry. OR
• PhD in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with six (6) years’ experience in sterile pharmaceutical industry

Required Experience and Skills:

• 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. Good teacher.
• 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.
• Quality Risk Management
• Expert knowledge of topics related to sterile, non-sterile, or biologic processing and/or microbiology methods including contamination control.
• Experience in transforming GMP compliance and highly experienced in regulatory inspections and responses.
• Excellent spoken and written English.  Demonstrates strong leadership capabilities and ability to work cross functionally to develop solutions and champion a position. 
• Demonstrated ability to effectively work hands-on with shop floor personnel. Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control.
• Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA, EMEA, TGA, ANVISA, and PMDA.
• Knowledge of USP and EU compendia and ISO industry standards.
• Quality Risk Management knowledge and experience.

Preferred Skills:

• External involvement in Industry organizations and groups is desirable

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US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As