Director, Quality & Compliance

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are 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 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 future–and yours. For more information, click here.

Role reports to:

Location:

Work Location:

What you will do

Accountable to provide leadership and to guide and manage the Quality activities to assure that all products produced at Lititz meet company and regulatory standards.  Lead Good Manufacturing Practice (GMP) compliance efforts and assure alignment with regulatory compliance systems and Kenvue procedures. Develop the organization’s strategies, goals and objectives in accordance with company’s strategy.

Key Responsibilities

• Directs the implementation and administration of quality management systems in accordance with applicable standards
• Oversees the development and implementation of processes, procedures, audits and corrective actions.
• Ensures effective communication and training are deployed throughout the business.
• Primarily at a Local and Regional Level.
• Provides overview or detailed communications to Q&C and cross-functional leadership on status of initiatives and issues.  This communication occurs at a plant-level, and occasionally at a regional-level.
• Is accountable to deliver a broad range of safety, quality and customer service metrics at the plant level, through individual and team execution. 
• Develops tactics to ensure successful delivery of goals, securing resources and identifying accountability.
• Is knowledgeable to execute quality systems including risk management, investigations, change control and CAPA. 
• Has a working knowledge of at least one other system including production, packaging and labeling, facilities and equipment, materials or laboratory controls.
• Troubleshoots and solves high risk and high complexity issues, using experience, ingenuity and creativity to implement solutions across a wide range of root causes.
• Lead the design and implementation of safety, Q&C, customer service and cost improvement programs and initiatives.  Innovate solutions to significant quality system gaps and lead continuous improvement projects.
• Is accountable for product disposition and compliance decisions at the plant level.  Escalates when required by procedure, or when potential impact to safety, systemic compliance, customer service or at significant cost.
• Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, design control, and quality systems.
• Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.
• Organizes, plans, leads and manages quality related projects in alignment with company goals.
• Monitors supplier quality related activities to assure fulfillment of contract/purchase order requirements.
• Facilitates the development and training of immediate staff.
• Primary point of contact with all health authorities.
• Cultivates a culture of quality, acting as the voice of Q&C during plant-level interactions. 
• Has a high degree of shop-floor presence (when applicable – might be QA 26 or Lab 26); is visible to employees at all levels of the plant organization as a Q&C leader
• Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions and recommendations in case of QRB and Escalations.
• Identifies, recruits and develops high-performing talent. 
• Ensures a strong pipeline of talent for critical positions. 
• Manages performance of direct reports, and provides input to talent processes for other individuals in the Q&C organization

What we are looking for

Required Qualifications

• Minimum degree in Science / Engineering or related discipline .
• A minimum of ten (10) years of GMP experience (or seven (7) years of experience in a QA role, with plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production

Desired Qualifications

• Master’s Degree in Engineering / Science / Administration (In Supply Chain/Business) considered an asset
• Expert knowledge of cGMP requirements and current Health Authority (i.e. FDA, ANVISA, Health Canada, MHRA) enforcement issues across multiple regulatory classes (Rx, OTC, Cosmetic, Medical Device).
• Demonstrated ability to lead cross-functional local teams, and participate in regional teams to accomplish business objectives, enhance relationships, and inform management to drive change and provide direct feedback.
• Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.

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What’s in it for you

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

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