Role reports to:
Head of Laboratory Excellence

Location:
North America, United States, New Jersey, Summit

Work Location:
Hybrid

What you will do

This is an exciting and potential growth role! You will work closely and in conjunction with the Head of Laboratory Excellence - North America. In this role, you will provide the framework for execution of strategies and the oversight of implementation tactics. Your scope will include key systems, processes and investments, supporting internal and external Plants. You will also become single point of contact across the regional portfolio of all activities of under Laboratory Excellence. You will represent the voice of the Region in many related governance forums. These include base business execution, strategic support and compliance focus.

The Lab Excellence Manager is responsible for establishing and maintaining quality assurance programs and controls to ensure product and process compliance with company and regulatory standards. You will providing guidance to teams to drive continuous improvement and operational excellence:

Key Responsibilities

• In conjunction with the Head of Lab Excellence, this role leads the framework and strategies of the External Contract Labs, Internal Manufacturing Labs, and Technical Support Opportunities This role collaborates with the team of Technical and Quality leaders/professionals to actively aid in executing the development of regional strategies, tactics and programs related to Laboratory initiatives to achieve short-term and long-term goals.
• This role monitors and actions around regional Laboratory performance to ensure that the efficiencies and quality meets Kenvue and Regulatory standards.
• Base Business: Lead the harmonization and standardization of Laboratory processes and maximize standard methodologies within the region and across the globe. Partners with MAKE and MAKE Excellence in support of Financial, Service and Quality Lab critical metrics.
• Strategic Support: Based on regional initiatives, provide strategic support for continuous improvement initiatives, programs, processes and governances with the region. Partner with Finance and E2E functions ensuring strategic investments in the region are aligned to LCM of equipment and in tandem with MAKE Q&C Strategic Plan.
• Compliance: Act as regional continuous improvement liaison between the Plants' Laboratories (Internal, External and Contract Labs) and Regulatory Compliance on Inspection Readiness, GMP, Micro and internal audits as well as 3rd party audits and management action plans, including gaps closures identified.

What we are looking for

Required Qualifications

• Bachelor's degree or equivalent in a relevant scientific or technical discipline is required
• 8-10 years of Pharmaceutical/OTC and/or Cosmetic experience required with a demonstrated ability in a leadership role of QC in MAKE Quality and/or Compliance in a regulated QA environment is required
• Knowledge of FDA Regulations, specifically 21 CFR 210 and 211, and experience in QMS related to inventory release/control/MRP/DRP systems, SAP is required
• Prior experience in Supervision and management of professionals in a QA or QC Lab, with broad-based experience or combination of experience, in pharmaceutical manufacturing, Quality Operations, Regulatory Compliance or Regulatory Affairs functions is required
• Experience working at a regional level and in matrix organizations and global interactions or global projects with cross functional collaboration is required
• Change-management experience and be a proven change agent as to DELIVER in a highly agile and complex environment is required
• Strong influencing and demonstrated teamwork experience
• Excellent strategic planning, problem-solving, and decision-making skills with a focus on continuous improvement
• Exceptional communication skills, both written and verbal, with strong attention to detail and accuracy
• Chemistry or Microbiology knowledge
• Worked and flourished in a matrix environment. This includes working in and with complexity, ambiguity, influencing without authority, and operating effectively in teams and squads.
• Energetic, with strong interpersonal, organizational and communication skills, Self-motivated.
• Strong organizational skills & must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment
• Ability to travel up to 25%

Desired Qualifications

• Project Management experience and knowledge of Process Excellence tools such as FPX, is highly preferred

• Ability to define problems, collect data, establish facts and draw valid conclusions is preferred

• Data driven foundational skills including able to extract insights when evaluating complex data to put forth recommendations to improve the business at hand are preferred

• Working knowledge of global complaint handling processes is preferred

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What's in it for you

Annual base salary for new hires in this position ranges:

$124,100.00 - $175,200.00

This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks
• 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.