Associate Director Quality Assurance

Job Description

The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics.  

 

In the Associate director role, the incumbent will provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories for assigned topics. Supports 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. Supports divisional projects across internal and external sites.  Supports development of strategy to drive compliance and continuous improvement in the network.  Delivers support for regulatory inspections and responses.

 

The incumbent must be experienced in one or more subject areas including low bioburden operations, sterile/aseptic manufacturing and facility design, microbiological and/or adventitious agent contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection and critical utilities. This role will require collaboration and global coordination of work across Quality and above site groups. Responsibilities contain Quality, regulatory, and business elements.

 

The incumbent will be responsible for:

• Developing, authoring, and maintaining the divisional quality standards in alignment with regulatory requirements, cGMP expectations, and industry trends

• Assisting manufacturing sites and project teams with project strategy, regulatory interactions, development of responses to inspection observations, QMS compliance, significant microbiological investigations, and guidance regarding corrective actions

• Championing company initiatives and projects to improve compliance and consistency in practices across the company in the designated area of expertise

• Participating in external industry and regulatory forums to stay abreast of industry trends

• Establishing/maintaining industry-leading expertise in the designated subject area(s)

 

Education Minimum Requirement:

• B.S., M.S. or Ph.D. (equivalent degrees acceptable) preferably in Science or Engineering such as Microbiology, Biology, Biochemical Engineering, Pharmacy, or related science discipline.

 

Required Experience and Skills:

• Minimum 8 years in pharmaceutical, biopharmaceutical, vaccine or medical device industry.

• Technical problem-solving abilities

• Strong communications, planning and collaboration/negotiation skills

• Technical writing proficiency

• Knowledge of international GMPs and Quality Management requirements of various regulatory agencies (e.g. US FDA, EMEA, TGA, PMDA, etc.) as well as USP compendia, EU compendia and ISO industry standards

• Ability and willingness to travel to the manufacturing sites in USA, Europe, Latin America and /or Asia for up to 20% of the time

 

Preferred Experience and Skills:

• Advanced subject expertise in one or more of the following areas:  low bioburden operations, microbiological contamination control, virology, adventitious agent contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection, critical utilities, microbiology methods

• Highly experienced in regulatory inspections and response preparation.

• 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

• Quality Risk Management knowledge and experience. #VetJobs #EBRG's

Required Skills:

Adaptability, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Change Management, Communication, Contamination Control, Cross-Cultural Awareness, Cross-Functional Teamwork, Environmental Monitoring, GMP Training, Inspection Readiness, Leadersh