Kenvue
Quality Lead- External MFG, Nutritionals
Kenvue, Skillman, New Jersey, us, 08558
Kenvue is currently recruiting for:
Quality Lead - External MFG, Nutritionals
This position reports into External Manufacturing Quality Management and will be located in Skillman, NJ.
Who we are
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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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:
External Manufacturing Quality Management
Location:
Skillman, NJ ((Kenvue's corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.)
Travel %:
10%
Pay : $92,000 - $149,500
What you will do
The Quality Lead - External Manufacturing, Nutritionals position provides overall Quality Assurance Leadership in the management of contract manufacturing sites engaged in the production of oral ingestible and topical Dietary and Nutritional products for the Zarbee's Business Unit of Kenvue ensuring compliance to 21CFR111 and 21CFR117. The external Manufacturing Quality Lead is responsible for supporting Contract Manufacturing sites, driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reporting Contract Manufacturer performance metrics, interfacing with Zarbee's and Kenvue business partners and providing batch record release when required. This position may represent QA on projects and improvement teams by guiding and setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support. This individual will comply with Federal and worldwide regulations and meets the needs of the business and supply chain.
Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas. A mentor to junior staff.Provides overview or detailed communications to Q&C and cross-functional leadership on status of key initiatives and issues.Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation of similar quality.Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues. Ensure timeliness of deliverables through independent, proactive intervention. May act as a CAPA owner or be assigned as QA lead resource for a CAPA.Troubleshoot high risk/high complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to 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 NA Source Quality on multiple, simultaneous, high-impact/ high-value projects as the "Voice of Quality", including active team engagement, proactively ensuring quality and compliance inputs areintegrated into the project objectives, and act as a QA "go-to" resource for cross-functional business partnersIs accountable to deliver a set of metrics for safety, quality and customer service that map to the plant objectives. Ensures that individual and team goals are aligned.Independently manage and prioritize highly complex and diverse workload ensuring deliverables are on-time, accurate, and meet their intended objective.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, development plans, procedures, and other documents, as required by procedure.Leads the development and introduction of new processes and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency.Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations in case of Quality Review Board and Escalations.What we are looking for
Qualifications
A minimum of a Bachelor's Degree (BA/BS) is required. Minimum of 6 years of related business/work experience required. A focused degree in Engineering, Chemistry, Biology, or Biological Sciences is preferred. Proficiency in MS Project, MS Excel and Portfolio management software preferredA minimum of 5-7 years of GMP experience (or 4-6 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 ProductionProven ability to lead and influence others within product teams with excellent communication and presentation skills.Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries, and influencing without authority required.Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability required.What's in it for you
Competitive Total Rewards Package*Paid Company Holidays, Paid Vacation, Volunteer Time & More!Learning & Development OpportunitiesEmployee Resource Groups
*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.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
#vdh
Quality Lead - External MFG, Nutritionals
This position reports into External Manufacturing Quality Management and will be located in Skillman, NJ.
Who we are
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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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:
External Manufacturing Quality Management
Location:
Skillman, NJ ((Kenvue's corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.)
Travel %:
10%
Pay : $92,000 - $149,500
What you will do
The Quality Lead - External Manufacturing, Nutritionals position provides overall Quality Assurance Leadership in the management of contract manufacturing sites engaged in the production of oral ingestible and topical Dietary and Nutritional products for the Zarbee's Business Unit of Kenvue ensuring compliance to 21CFR111 and 21CFR117. The external Manufacturing Quality Lead is responsible for supporting Contract Manufacturing sites, driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reporting Contract Manufacturer performance metrics, interfacing with Zarbee's and Kenvue business partners and providing batch record release when required. This position may represent QA on projects and improvement teams by guiding and setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support. This individual will comply with Federal and worldwide regulations and meets the needs of the business and supply chain.
Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas. A mentor to junior staff.Provides overview or detailed communications to Q&C and cross-functional leadership on status of key initiatives and issues.Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation of similar quality.Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues. Ensure timeliness of deliverables through independent, proactive intervention. May act as a CAPA owner or be assigned as QA lead resource for a CAPA.Troubleshoot high risk/high complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to 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 NA Source Quality on multiple, simultaneous, high-impact/ high-value projects as the "Voice of Quality", including active team engagement, proactively ensuring quality and compliance inputs areintegrated into the project objectives, and act as a QA "go-to" resource for cross-functional business partnersIs accountable to deliver a set of metrics for safety, quality and customer service that map to the plant objectives. Ensures that individual and team goals are aligned.Independently manage and prioritize highly complex and diverse workload ensuring deliverables are on-time, accurate, and meet their intended objective.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, development plans, procedures, and other documents, as required by procedure.Leads the development and introduction of new processes and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency.Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations in case of Quality Review Board and Escalations.What we are looking for
Qualifications
A minimum of a Bachelor's Degree (BA/BS) is required. Minimum of 6 years of related business/work experience required. A focused degree in Engineering, Chemistry, Biology, or Biological Sciences is preferred. Proficiency in MS Project, MS Excel and Portfolio management software preferredA minimum of 5-7 years of GMP experience (or 4-6 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 ProductionProven ability to lead and influence others within product teams with excellent communication and presentation skills.Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries, and influencing without authority required.Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability required.What's in it for you
Competitive Total Rewards Package*Paid Company Holidays, Paid Vacation, Volunteer Time & More!Learning & Development OpportunitiesEmployee Resource Groups
*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.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
#vdh