Quality Manager, External Manufacturing

The Manager, External Manufacturing Quality (EMQ) is responsible for ensuring that third party manufacturers of Kenvue products meet all quality, compliance, and regulatory expectations across a diverse North America portfolio that includes OTC drugs, cosmetics, medical devices, and combination products. This leadership role oversees quality systems performance at external manufacturing sites, provides risk based quality direction, and ensures products consistently meet Kenvue and Health Authority requirements. 

Key Responsibilities:  

• Own quality oversight for an assigned portfolio of External Manufacturing (EM) sites, ensuring robust quality systems and consistent compliance across multiple product classes and technologies. 

• Lead a team of Quality Leads/Specialists, driving their development, performance, and engagement. 

• Partner with EM site leadership and cross-functional Kenvue teams to set clear expectations, align on quality strategy, and proactively manage quality/compliance risks in a highly matrixed environment. 

• Lead quality issue management for EM operations, including deviation/nonconformance assessment, investigations, root cause analysis, and CAPA plans to drive timely, sustainable remediation. 

• Ensure inspection readiness and compliance execution by leading/participating in internal audits, external audits, and regulatory inspections; oversee effective responses and follow-through on commitments. 

• Provide quality governance for EM deliverables, including review/approval of key quality documentation (e.g., batch disposition decisions, change controls as applicable, and Annual Product Reviews) to ensure adherence to Kenvue standards and health authority expectations. 

Qualifications:  

Required:  

• A minimum of a bachelor’s degree is required. A focused degree in a Science related discipline is preferred. An advanced degree (Master’s/MBA) is preferred.  

• Minimum of 8 years of experience working in a regulated industry is required.  

• 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. 

• Experience in managing quality activities for large volume external manufacturing and supplier sites ensuring compliance with applicable regulations.  

• 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.  

• Experience in the facilitation of internal and external audits and regulatory inspections.  

• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability 

• Results-oriented with strong track record of success in delivering on objectives  

• Ability to travel (within North America) up to 30–50%.

Desired:  

• Experience in either Pharmaceutical, Medical Device Manufacturing, OTC Drug and/or Cosmetic production is preferred.  

• Experience with QA or QC directly or indirectly is preferred.