Associate Director, Quality Assurance

Merck•Upper Gwynedd Township, PA

2d•Hybrid

About The Position

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 company 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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)