Sr Manager, Microbiological Quality and Sterility Assurance PLCM

Kenvue is currently recruiting for:

Sr Manager MQSA Regional PLCM

This 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 are

At 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 %: 15

Pay: In the US this position ranges from $119,000 - $205,850   

What you will do 

The 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 Responsibilities

·    MQSA representative in the receipt of NPI/NPD transfer process and qualification of manufacturing sit