Senior Manager, Ext Mfg. Quality

Kenvue

$153K — $217K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a science-related discipline preferred.
  • Minimum of 8 years in a regulated industry, with OTC drug or cosmetic manufacturing experience desired.
  • Knowledge of cGMP, FDA enforcement issues, and regulatory authority practices required.
  • Experience managing quality for large volume external manufacturing and supplier sites.
  • Strong collaboration skills with internal and external partners essential.
  • Experience handling internal/external audits and regulatory inspections.
  • Proficient in root cause analysis techniques and systematic problem-solving.

Responsibilities

  • Lead EMQA team for operational and tactical support at assigned EM sites.
  • Ensure compliance and quality at EM sites as the primary quality leader.
  • Make key decisions on significant compliance issues without needing director-level approval.
  • Drive strategy and execution for site remediation and continuous improvement.
  • Review and approve quality documents such as investigations and annual product reviews.
  • Collaborate across functions to resolve issues and enhance processes.
  • Mentor and develop team members to enhance capabilities and support succession planning.

Benefits

  • Competitive benefit package including health and wellness offerings.
  • Paid company holidays, paid vacation, and volunteer time.
  • Opportunities for learning and development.
  • Participation in Kenvue Impact Networks.
Full Job Description


Role reports to:
Director, External Mfg Quality Assurance

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

Work Location:
Hybrid

What you will do

The Senior Manager, External Manufacturing Quality (EMQA) is responsible for overseeing a defined portfolio of External Manufacturing (EM) sites and/or product categories within Skin Health/Essential Health. You will balance strategic priorities with hands-on operational oversight at EM sites, and provide tactical leadership, ensuring alignment with EMQA functional objectives.

Key Responsibilities
  • Provide operational and tactical leadership of the EMQA team supporting assigned EM sites and/or product categories.
  • Ensure manufacturing quality and compliance across assigned EM sites, acting as day-to-day quality leader.
  • Serve as decision maker for high-impact compliance issues that do not require Director (D1) alignment.
  • Lead strategy and execution for EM site remediation and continuous improvement initiatives.
  • Review and approve Level 2 investigations (INVs), OTC NDA Annual Product Reviews (APRs), and additional quality documents as required.
  • Collaborate cross-functionally within a matrix structure to resolve issues, drive efficient processes, and maintain compliance.
  • Coach, mentor, and develop direct and indirect reports to strengthen functional capability and support succession planning.
  • Monitor performance, drive accountability, and ensure EMQA activities align with overall Kenvue quality expectations.


What we are looking for

Required Qualifications
  • A minimum of a bachelor's degree is required. A focused degree in a science-related discipline is preferred.
  • A minimum of 8 years of experience working in a regulated industry is required. Experience in over-the-counter drug and/or cosmetic manufacturing is highly desired. Experience with pharmaceutical and/or medical device manufacturing is a plus.
  • Working knowledge of cGMP requirements, current FDA enforcement issues and current regulatory authority enforcement practices is required. Working knowledge of process validation, cleaning validation, manufacturing and packaging equipment train designs, microbiological controls, and assessing compliance to regulations is required.
  • Experience in managing quality activities for large volume external manufacturing and supplier sites ensuring compliance with applicable regulations.
  • Demonstrated ability to collaborate with internal and external partners to enhance relationships and interactions.
  • Experience in the facilitation of internal and external audits and regulatory inspections.
  • Demonstrated ability to build respectful and productive relationships with subordinates, peers, and leadership partners across multiple responsibility levels and within a high matrix structure is required.
  • Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
  • Demonstrated ability to lead as a key team member, developing strategy/plans and implementing successful outcomes is required.
  • Demonstrated ability to address complex issues using deductive reasoning, critical analysis skills and systematic approaches is required.
  • Demonstrated working knowledge of root cause analysis techniques including but not limited to: brainstorming, data collection and analysis tools, 5-whys, Fishbone (cause and effect), FMEA, and DMAIC is required.
  • Results-oriented with strong track record of success in delivering on objectives.
  • Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.


Desired Qualifications
  • Experience with QA or QC directly or indirectly is preferred.
  • Professional Certification with Six Sigma Black or Green Belt is preferred.


What's in it for you

Annual base salary for new hires in this position ranges:

$153,850.00 - $217,200.00

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.

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