Head of Regional R&D Quality

Come work at the forefront of science – and help the brands you grew up with grow and evolve into the next generation.Job Description – Head of Regional R&D Quality (2407025720W)The Head of R&D Quality & Compliance (Q&C) in EMEA is a member of the EMEA Q&C Leadership Team. The Head directs employees at the sites performing R&D Q&C activities within the region to ensure an integrated, comprehensive risk-based quality monitoring system for GMP, Analytical, and Micro activities is developed, implemented, and maintained. Quality monitoring activities include but are not limited to:Functions as an advisor concerning Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) and provides appropriate compliance guidance to employees and R&D personnel.Contributes to the implementation of processes and systems that lead to the collection of data relevant to reporting, evaluating, and actions on quality metrics.Participates in Regional R&D and Quality & Compliance leadership teams.Collaborates with other members within the EMEA Quality & Compliance leadership teams and R&D in identifying areas of continuous improvement to the global quality management framework of R&D within Kenvue.Acts as the single point of contact for the region and ensures appropriate escalation processes are implemented.Leads efforts for establishing 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.Performs interdepartmental and cross-functional strategic planning and conducts L&A activities, as required.Responsible for the development of all employees 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 that encourages the company’s credo, commitment to equal employment opportunity, and the value of a diverse workforce.Major Duties & ResponsibilitiesProvide strategic management oversight and leadership to the EMEA R&D Quality & Compliance organization, implementing quality monitoring programs to proactively 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.Provide ongoing mentoring, coaching, and development of R&D Quality & Compliance employees.Ensure employees are trained in procedures and systems associated with their assigned tasks.Perform administrative tasks associated with performance reviews, salary administration, and other personnel tasks.Responsible for the regional budget planning process and management of regional Website qualified employees for the department and ensures employees have the education, experience, and tools to appropriately function as advisors of GMP, Good Documentation Practices, and other applicable requirements.Participate in the Regional R&D and the Regional Quality & Compliance Leadership Teams, providing R&D Quality & Compliance support to strategic discussions/decision making. Lead R&D Management Reviews and other compliance activities in the regions and escalate issues appropriately. Collaborate within and across regions and with Global Regulatory Compliance & Standards 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 strategic direction and leadership to drive continuous process improvements within R&D and within Quality & Compliance, ensuring appropriate interpretation of company and regulatory policies and requirements.Provide R&D Quality & Compliance support for any inspection within the region. Participates and/or manages business activities relating to Health Authority inspections/company audits, liaising with other Quality & Compliance organizations as appropriate.QualificationsRequired Minimum Education: Master’s degree in Pharmacy, Chemistry, Engineering, or related scientific field.Required Years of Related Experience: 10+ years in a regulated industry. Good knowledge of GMP regulations in Pharmaceutical, Medical Device, and Cosmetic product classifications. Minimum of 10 years of Quality experience and 7 years of people management experience.Required Knowledge, Skills, and Abilities:Experience of the overall product development process.Expert knowledge of applicable regulatory requirements (cGMPs) governing various product classification types (OTC, Herbals, Food Supplement, Medical Devices, cosmetic).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 employees 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.Required Years of People Management Experience: 7Preferred Knowledge, Skills, and Abilities:Ability to inspire and energize others to execute a vision, provide guidance and direction, and make difficult decisions.Ability to lead and communicate complex technical or non-technical concepts to non-technical stakeholders.Ability to proactively engage and align stakeholders, capabilities, and resources to achieve company objectives.Ability to adapt to changing circumstances and work effectively in a fast-paced environment.Ability to analyze complex, simultaneous issues using critical thinking, problem-solving, and sound judgment skills.Knowledge and experience in GCP, GLP, and other related requirements.Key Working RelationshipsInternal – R&D, Quality (various), Compliance, Materials (R&D), Procurement, Operations (Supply Chain).External – Raw Material Suppliers, Third Party Manufacturers.Supervisory Responsibilities2 direct reports, 10 indirect reports.In general: Master the ability of innovation, complexity, understanding the customer/marketplace, interdependent partnering, and organizational and people development.Strong Influencing Skills: Ability to influence Executive Management across all functions. Develops win-win strategies to ensure success for all parties. Ability to drive enthusiasm and engagement at all levels.Communication Skills: Ability to make the complex clear and compelling. Articulates strategy and delivers clear messages appropriate to the audience. Knows when to zoom in and out on detail.Strategic Thinking: Takes the organization to new ways of thinking. Develops clear strategies for the business that are aligned to company vision.Big Picture Orientation: Implements world-class processes and systems that significantly improve business operations on a regional/global as well as on a local scale. Skillfully balances the need to deliver short-term business results with what is best for the organization in the long term. Considers the impact of decisions on patients, compliance, and business.Primary LocationKenvue 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. #J-18808-Ljbffr