Senior Manager, R&D Quality & Compliance

Kenvue•Summit, NJ

1d•Hybrid

About The Position

Kenvue is currently recruiting for a: Senior Manager, R&D 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: Reg Franchise Quality Ldr Skin Health Location: North America, United States, New Jersey, Summit Work Location: Hybrid What you will do The Senior Manager, R&D Quality & Compliance (Q&C) directs staff performing R&D Q&C activities at a site or function to ensure an integrated and comprehensive quality monitoring system for GMP, Analytical and Micro, and GLP activities is developed, implemented and maintained. Quality monitoring activities include but are not limited to the quality reviews of key documents; review of metrics and support of CAPA activities for Non-conformances/Deviations, Audits, Change Control, and Health Authority inspection activities, and evaluation/implementation of corrective and preventative actions for effectiveness; review of activities to ensure ongoing inspection readiness. Responsible for ensuring the timely and accurate completion of departmental R&D Quality & Compliance deliverables, management of CAPAs/NCs. Functions as an advisor concerning Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP), and provides appropriate compliance guidance to staff and R&D personnel. Contributes to management of processes and systems that lead to collection of data relevant to reporting quality metrics. Acts as the single-point of contact for assigned Site or Function/COE, and ensures appropriate escalation processes are implemented. Leads efforts for maintaining R&D Quality & Compliance processes and guidelines and participates in process improvement projects, departmental decision-making, recruitment, resource assessments, budget management and end of year performance evaluations. Assists Regional Head with interdepartmental and cross-functional strategic planning. Responsible for the development of all employees at a Site or Function/COE within the department by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs. Provide an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.

Requirements

Bachelor’s degree or equivalent in Engineering, Science, or a related field with a strong foundation in quality assurance principles and R&D processes.
9+ years in a regulated industry.
Good knowledge of GMP and GLP regulations in Pharmaceutical, Medical Device and Cosmetic product classifications.
A minimum of 5 years of Quality experience
A minimum of 3 years of people management experience

Nice To Haves

Experience of the overall product development process.
Expert knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices).
Ability to allocate and balance resources across competing priorities; identify leveraging opportunities and solutions, and mentor others to do the same.
Ability to provide guidance, collaborate, negotiate, and effectively coach and direct departmental staff and others to ensure an ongoing state of compliance.
Strong people management experience.
Ability to engage and align with other diverse and dispersed organizations and functions.
Ability to negotiate, influence and lead with and without direct line authority, and to engage others and lead an organization through continuous improvement and change.
Ability to work and make compliance decisions independently and on multiple projects.
Excellent knowledge of English is required and proficiencies in Microsoft Office applications.

Responsibilities

Provide management oversight of the R&D Quality & Compliance organization within the assigned site or function, maintaining quality monitoring and assessment programs to ensure the R&D organization is operating in compliance with company/division policies and procedures, as well as applicable regulatory requirements.
Ensure innovative compliance solutions are identified, when possible, to address project and process challenges.
Ensure effective deployment of R&D Quality & Compliance resources to meet the current and future needs of the R&D organization.
Provides ongoing mentoring, coaching and development of R&D Quality & Compliance staff.
Ensures staff are trained on procedures and systems associated with their assigned tasks.
Perform administrative tasks associated with performance reviews, salary administration, and other personnel issue.
Recruits/hires qualified staff for the department and ensures staff have the education, experience and tools to appropriately function as advisors of GMP, GLP and Good Documentation Practices.
Participates on R&D compliance committees (e.g., CAPA reviews, Management Reviews, etc) in the regions and escalate issues appropriately.
Collaborate across regions and with Global Quality Management Systems (GQMS) to evaluate compliance trends and ensure adequate action plans are developed, implemented and evaluated for effectiveness.
Interpret regulations to provide risk analysis guidance and make decisions about R&D GxP activities as they apply to products, processes, practices and procedures.
Responsible to be an ambassador for change to ensure compliant processes and systems are established and maintained to meet the changing regulatory environment.
Provide R&D Quality & Compliance support for any inspection within the assigned region.
Participates and/or manages business activities relating to Health Authority inspections/company audits, liaising with other Quality & Compliance organizations as appropriate.