External Manuf Quality Manager - 2 Roles

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.

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What you will do

The QA Manager, External Manufacturing Quality is primarily responsible for ensuring that 3rd-party organizations who are manufacturing, packaging, controlling, and handling Kenvue products fully understand and meet Kenvue quality and compliance expectations. The NA EM product portfolio consists of both oral ingestible and topical OTC drugs, medical devices, combination products, NDA’s, cosmetics, engineered products, etc. for Kenvue. This position provides risk-based QA direction, perspective, and support to a range of technical, compliance and business issues pertinent to EM products, processes, programs, and activities. This is a leadership position within the EM quality unit. The position provides key input in the development of strategies, goals, and initiatives, with the authority and responsibility to manage their effective deployment and execution. This position has direct responsibility for a team of professional employees (Quality Leads and Specialists) at multiple levels of experience, training, and skills. The QA Manager is expected to manage team member development, performance, and empowerment consistent with the goals and expectations of Kenvue and the Make Quality organization.

Key Responsibilities

• Responsible for the performance of a select portfolio of EM sites that may include multiple product classes, technologies, and complexities. Responsible for oversight of quality systems aspects as applicable.
• Develop, implement, and oversee execution of strategies, plans, and initiatives to ensure production of Kenvue products that consistently meet Kenvue and Health Authority requirements for Quality and compliance.
• Develop aligned, respectful, and productive relationships with Kenvue and EM peer and leadership partners across multiple responsibility levels and within a high matrix structure. Work with senior leadership to advance the organization and drive improvement.
• Set reasonable expectations, gain agreement, develop mutually accepted actions, and coordinate execution strategies. React decisively to a wide range of non-conformance events, CAPAs, and other quality/compliance indicators.
• Drive short and long-term remediation actions that meet requirements and create an improved future state. Provide expertise, oversight, mentoring, and guidance to others, developing expertise and driving decision-making capabilities to lower levels and across functions.
• Drive system and process improvements to deliver enhanced team performance.
• Approve the work of others, ensuring quality and compliance to strategies, plans, standards, procedures, and health authority regulations. Review and approve Annual Drug Product Reviews.
• Lead and/or participate as a key contributor to cross-function, cross region, cross sector teams addressing high complexity/high impact issues, initiatives, and strategies.
• Maintain the voice of Make Quality, while assuming a global business partner perspective. Develop a fully effective, motivated, engaged, and compliant team of direct and indirect employees. Develop and implement experience and skill development strategies that best position the team to meet current and future business needs. Work in cooperation with each employee to develop personal career strategies.

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in Engineering, Science, or a related field
• A 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 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.
• Demonstrated skills navigating within a matrix environment, managing complexity, collaborating across boundaries, and influencing with and without line authority is also required.
• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
• Demonstrated ability to lead and/or work 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.

Desired Qualifications

• 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.

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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.