MSD Global Quality Compliance Associate Director 

United States, Upper Gwynedd Township 

797049637

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, sterility assurance and microbial analytics 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 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.

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• Creating awareness to the shop floor for viral safety and risks associated with our processes and its manipulations.

• Fulfilling a role as internal consultant within our company usingin-depth understanding of contamination control, viral risks and the viral clearance concepts in vaccines and biotech manufacturing process.

• Providing responses to queries (RTQs) and inspection support (e.g. FDA, EMA, China) including responses to agency follow up questions.

• Networking with your peers in MQSA, Analytical Science groups and Research Laboratories to assure end-to-end suitability of our strategies and to learn and develop in the field of pharmaceutical virology.

• 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)

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Contingent Workers apply

US and Puerto Rico Residents Only:

if you need an accommodation during the application or hiring process.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by aagreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:08/07/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.