Sr Manager, Microbiological Quality and Sterility Assurance PLCM

DescriptionKenvue is currently recruiting for:Sr Manager MQSA Regional PLCMThis position reports to Head of Microbiological Quality & Sterility Assurance (MQSA) and is based at Skillman, NJ USA (relocating to Summit NJ, starting Q2-25).Who we areAt Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's and BAND-AID Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .Role reports to: Head of Microbiological Quality & Sterility Assurance (MQSA)Location: Kenvue's corporate headquarter is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.Travel %: 15Pay: In the US this position ranges from $119,000 - $205,850What you will doThe Senior Manager of Microbiological Quality and Sterility Assurance Product Life Cycle Management (PLCM) will be responsible for supporting the R&D, Pilot Plant, MQSA-NPI/NPD and QHS teams in the development and transfer of scaled-up microbiologically controlled processes. They will lead the characterization efforts of the large-scale manufacturing processes ensuring a successful scale-up and transfer from lab-scale/pilot plant to the commercial manufacturing facilities. Responsibilities will include, but not be limited to, championing proactive quality through process design in alignment with design for microbiological controlled manufacturing principles, approval of transfers from pilot stages to scale-up, approval of MQSA technical documents, lead root cause analysis and CAPA investigations associated with manufacturing design, will be involved in the maintenance of suppliers through MRAs and qualification of direct material suppliers, lead MRAS as part of production life cycle, approval of change controls prior to the adoption of new suppliers in the commercial manufacturing environment and material source changes, definition of microbiological critical process parameters and cleaning and sanitization (C&S) development and validation, and approval of technical reports generated from compliance programs (e.g. regulatory inspections, regulatory commitments, and global non-conformances and CAPAs among others). This role location will align with the strategic locations defined by the QHS organization at the regional level.The MQSA Senior Manager will also serve as the regional process and/or program owner for Kenvue's microbial contamination control programs associated with continued product and portfolio reliability, associated with infection prevention and introduction of rapid technology.Key ResponsibilitiesMQSA representative in the receipt of NPI/NPD transfer process and qualification of manufacturing sites to meet product designDevelop microbial control critical process parameters to meet product CQAs at scale-upMicrobially control process design including cleaning and sanitization to support manufacturing requirements (e.g., campaign manufacturing)Maintain sterilization and microbial reduction technologies at the regionRoot cause analysis and CAPA determination associated with technical product investigations, including accountability to proactively identify and deploy CAPAs proven effectiveIdentification of proactive projects and activities to improve technical attributes of product performance, compliance, and reliability enabling rapid microbiological technologies and process analytical technologiesGlobal program and/or process ownership of one or more assigned Kenvue programs associated with continued product and portfolio reliability, compliance, and/or performanceSupport the validation and maintenance of the aseptic and/or sterilization processes from R&D to Pilot Plants followed by handing over to the regions as part of the manufacturing technology transfer. Will assist in the preparation of protocols and technical reports.Conduct training for manufacturing, laboratory, and management personnel, as needed, to support the implementation of microbiological quality and sterility assurance practices.Support internal and external manufacturing audit assessments to include suppliers (e.g., manufacturing of raw materials/components, contract labs, contract sterilization and manufacturing sites).Provide support during due diligence for acquisitions and integrations.Liaison to global industry, trade and standards organizations.What we are looking forRequired QualificationsBachelor's Degree in Microbiology, Biochemistry, Biotechnology or related scientific field.Minimum of 8-10 years of experience with evidence of progressive increase in responsibility in product development, quality, manufacturing, technical operations, or technical quality functions for regulated consumer products.Demonstrated ability to lead global programs with positive impact on product reliability, compliance, and/or performance through the creation of resilient programs for microbiological controlled products and processes.Technical understanding of Consumer technologies, product design, process controls...Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity