Sr Manager, Microbiological Quality and Sterility Assurance PLCM - 2407023932W

Description

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 (http://kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnsons 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 futureand yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .

Role reports to: Head of Microbiological Quality & Sterility Assurance (MQSA)

Location: Kenvues 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 Kenvues 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 sites to meet product design

• Develop microbial control critical process parameters to meet product CQAs at scale-up

• Microbially control process design including cleaning and sanitization to support manufacturing requirements (e.g., campaign manufacturing)

• Maintain sterilization and microbial reduction technologies at the region

• Root cause analysis and CAPA determination associated with technical product investigations, including accountability to proactively identify and deploy CAPAs proven effective

• Identification of proactive projects and activities to improve technical attributes of product performance, compliance, and reliability enabling rapid microbiological technologies and process analytical technologies

• Global program and/or process ownership of one or more assigned Kenvue programs associated with continued product and portfolio reliability, compliance, and/or performance

• Support 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.

Qualifications

What we are looking for

Required Qualifications

• Bachelors 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 and organizational capabilities in the areas of: Product & Process development for microbially controlled product, Sterile manufacturing via aseptic process, Non-sterile manufacturing, Terminal sterilization (Radiation, Gas & Heat and Filter Sterilization), Cleaning & Sanitization, Environmental Controls, Critical Utilities Design & Validation, Disinfection efficacy, Equipment and Facility Design, Qualification and Validation, Laboratory Controls, Design Controls

• Able to present to regulators

• Ability to collaborate effectively with cross-functional teams and business partners

• Exhibits discipline in execution

• Ability to identify problems, analyze data, and develop effective solutions

• Ability to think critically, make informed decisions, and solve complex problems

• Basic computer skills including, but not limited to, email, word processing, spreadsheet, and presentations

• Must be fluent in English

Desired Qualifications

• Advanced degree (Masters, Ph.D.) or additional studies in Microbiology, Biotechnology, or Sterilization Engineering

• 8 years of experience in product development resulting in successful product launches and/or product improvements. 8 years of experience in root cause analysis and/or leading complex investigations resulting in effective CAPA identification.

• Ability to communicate complex technical concepts to non-technical stakeholders

• Ability to proactively engage and align stakeholders, capabilities and resources to achieve company objectives

• Ability to adapt to changing circumstances and work effectively in a fast-paced environment

• Technical knowledge and experience in multiple technologies specific to the Consumer business

Whats in it for you

• Annual base salary for new hires in this position ranges from $ 119,000 to $205,850 . This takes into account a number of factors including work location, the candidates skills, experience, education level & other job-related factors.

• Competitive Total Rewards Package

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

• Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

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Primary Location NA-US-New Jersey-Skillman

Travel Yes, 10 % of the Time

Job Function Quality Assurance

Req ID: 2407023932W