Global Quality Compliance Associate Director

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.
• Interacting internally with product teams and externally with several global contract manufacturing organizations in EU, US and Asia to select, qualify and implement the appropriate adventitious viral agents detection methods and harmonize the viral control strategies, the viral inactivation and viral safety aspects of our processes.
• 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 using in-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)

Education Minimum Requirement:

• B.S., M.S. or Ph.D (equivalent degrees acceptable) preferably in Science or Engineering such as Microbiology, Virology, 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.
• Knowledgeable about the regulations on viral safety and industry expectations.
• Viral risk as part of Contamination control (facility).
• Viral risk as part of the production process (end-to-end)
• Viral clearance studies, disinfection efficacy, and viral inactivation methods. (filtration/chemical/low pH treatment).
• Experience with viral- and adventitious agents detection methods.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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.

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Relocation:

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Job Posting End Date:

*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.

Job Posting End Date:07/25/2024

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.

Requisition ID:R300254