External Manufacturing Quality Lead

Kenvue•Summit, NJ

4d•Hybrid

About The Position

The External Manufacturing Quality Lead provides overall Quality Assurance (QA) leadership for contract manufacturers producing OTC drugs, medical devices, cosmetics, and related products for Kenvue. Responsibilities include supporting contract sites; driving compliance and quality improvements; resolving nonconformance issues; monitoring complaints; reviewing annual reports; reporting performance metrics; collaborating with business partners; and providing batch release as needed. This position may serve as the QA representative on project and improvement teams, guiding the establishment of quality and compliance requirements, developing SOPs and specifications, and providing support for technical transfer and validation activities. The role also includes oversight of applicable quality systems.

Requirements

Bachelor’s degree or equivalent.
Minimum of six (6) years of relevant work experience in a GMP environment.
Experience leading and owning investigations, CAPAs, and/or CAPA action items or deliverables.
Demonstrated ability to design and implement quality and compliance improvement programs.
Detailed working knowledge of cGMP requirements and current FDA enforcement issues.
Proficiency in MS Word, Excel, and PowerPoint.
Demonstrated ability to lead cross-functional teams and collaborate with internal and external partners, including interfacing with senior management to inform, drive change, and provide direct feedback.
Demonstrated ability to work autonomously on complex or ambiguous issues with little or no daily direction.

Nice To Haves

Demonstrated expertise in developing and deploying innovative quality management systems within complex, regulated manufacturing environments.
Strong analytical acumen, including experience leveraging advanced data analytics tools to drive quality improvements and strategic decision-making.
Visionary mindset with the ability to anticipate future quality challenges and proactively design scalable solutions.
Commitment to embodying leadership imperatives and fostering a high-performance culture aligned with organizational values.

Responsibilities

Serve as a Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and proactively seek training and knowledge in adjacent areas. Act as a mentor to junior staff.
Provide detailed or summary communications to senior cross-functional leadership regarding the status of key initiatives and issues.
Document technically accurate, regulatory-compliant rationales for product disposition, risk assessment and mitigation, nonconformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation meeting similar quality standards.
Conduct, execute, and document thorough investigations and CAPAs for high-risk and high-complexity issues. Ensure timeliness of deliverables through independent and proactive intervention. May act as a CAPA owner or serve as the QA lead resource for CAPAs.
Troubleshoot high-risk and high-complexity quality and compliance issues using experience, ingenuity, and creativity to develop solutions addressing a wide range of root causes.
Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality system gaps and lead continuous improvement projects.
Represent Make Q&C on multiple simultaneous high-impact and high-value projects as the “Voice of Quality,” ensuring quality and compliance inputs are proactively integrated into project objectives. Act as a QA “go-to” resource for cross-functional business partners.
Independently manage and prioritize a highly complex and diverse workload, ensuring deliverables are on time, accurate, and meet their intended objectives.
Exercise independent decision-making authority and accountability for product disposition and compliance decisions with significant potential impact to customer service.
Review and approve compliance records, specifications, manufacturing site documentation, procedures, and other documents as required by procedure.
Lead the development and introduction of new processes and procedures that may impact multiple functions or regions. Propose innovative process improvements to drive compliance and/or efficiency.
Drive closure of MAPs through holistic and comprehensive engagement and negotiation with External Manufacturing (EM).