Johnson & Johnson Careers
External Manufacturing Quality Assurance NPI Lead
Skillman, New Jersey
Requisition ID: 5568181025
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON’S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR® Johnson & Johnson Consumer Inc is currently recruiting for an External Manufacturing Quality Assurance/NPI Lead in Skillman, NJ.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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.
The External Manufacturing Quality Assurance/NPI Lead position provides overall Quality Assurance leadership in the management of contract manufacturing sites engaged in the production of Cosmetics, OTCs, NDAs, Class I and II Medical Devices, and Combination Products for the J&J Consumer Sector. The Lead is responsible for supporting Contract Manufacturing sites, driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reviewing Annual Drug Product Review reports, reporting Contract Manufacturer performance metrics, interfacing with J&J business partners and providing batch release when required. The Lead will be responsible for complying with processes and controls ensuring that the performance and quality of new products conform to established standards and are in compliance with J&J Global and Regional policies and procedures, U.S. and Global Quality System Regulations (QSRs) including 21 CFR 210 & 211, 21 CFR 820 and 21 CFR Part 11 and current Good Manufacturing Practices. The Lead will be an integral member of project teams to ensure compliance and quality requirements are met during product development, scale up and validation.
• 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.
• Monitor/Report Contract Manufacturer performance metrics
• Manage tracking and timely closure of Contract Manufacturer audit observations
• Provide detailed or summary communication to senior 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. All documentation is first-pass approvable by QA Directors or Managers.
• 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 are integrated into the project objectives, and act as a QA “go-to” resource for cross-functional business partners.
• 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, new product introduction 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.
• Assume full QA oversight responsibility for high-complexity and/or high-risk new product introduction projects across multiple product, regulatory, and/or technology types.
• Partner with Technical Transfer / Support to Marketed Product teams to coordinate new product development and launch requirements, including validation and stability requirements in support of commercialization and documentation readiness.
• Proactively participate on new product development teams, including the selection and qualification of new sites and execution of project deliverables.
• Hold business partners accountable for meeting project development plan requirements, and independently drive timely completion of validation activities at external sites.
• Develop and deliver all QA clearance statements Right First Time for APR approval.
• Independently interact with senior Quality leadership to negotiate and influence quality decisions.
• A minimum of a Bachelor’s Degree is required.
• A focused degree in a technical field (Engineering, Sciences, or similar disciplines) is preferred.
• A minimum of 6 years of GMP experience in either Pharmaceutical, Medical Device Manufacturing, OTC Drug, Cosmetic, and/or Food and Dietary Supplements production (or a minimum of 4 years’ experience with an Advanced degree/MBA) is required
• ASQ Certification(s): CQE, CRE, CQA preferred.
• Experience in New Product Development Quality and Quality Systems is preferred. Experience in R&D, Process Development, Technical Transfer, Analytical Chemistry, Clinical Research, Microbiology or Product Safety is preferred.
• Experience with complaint vigilance and/or complaint reporting is preferred.
• Detailed working knowledge of cGMP requirements and current FDA enforcement issues is required
• Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback is required
• Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction is required
• Experience in MS Word, Excel, and Power Point applications is required
• Proven ability to lead and influence others within product teams with excellent communication and presentation skills is required
• Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority is required
• Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution is required
• Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability is required
• This position is located in Skillman, NJ and requires up to 10% domestic travel
United States-New Jersey-Skillman-
J & J Consumer Inc. (6101)