Director, Quality & Compliance

Director, Quality & Compliance

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Sr Director NA MAKE Q and C

Posizione:

North America, United States, Pennsylvania, Lititz

Luogo di lavoro:

Completamente in loco

Cosa farai

Accountable to provide leadership and to guide and manage the Quality activities to assure that all products produced at Lititz meet company and regulatory standards.  Lead Good Manufacturing Practice (GMP) compliance efforts and assure alignment with regulatory compliance systems and Kenvue procedures. Develop the organization’s strategies, goals and objectives in accordance with company’s strategy.

Key Responsibilities

• Directs the implementation and administration of quality management systems in accordance with applicable standards
• Oversees the development and implementation of processes, procedures, audits and corrective actions.
• Ensures effective communication and training are deployed throughout the business.
• Primarily at a Local and Regional Level.
• Provides overview or detailed communications to Q&C and cross-functional leadership on status of initiatives and issues.  This communication occurs at a plant-level, and occasionally at a regional-level.
• Is accountable to deliver a broad range of safety, quality and customer service metrics at the plant level, through individual and team execution. 
• Develops tactics to ensure successful delivery of goals, securing resources and identifying accountability.
• Is knowledgeable to execute quality systems including risk management, investigations, change control and CAPA. 
• Has a working knowledge of at least one other system including production, packaging and labeling, facilities and equipment, materials or laboratory controls.
• Troubleshoots and solves high risk and high complexity issues, using experience, ingenuity and creativity to implement solutions across a wide range of root causes.
• Lead the design and implementation of safety, Q&C, customer service and cost improvement programs and initiatives.  Innovate solutions to significant quality system gaps and lead continuous improvement projects.
• Is accountable for product disposition and compliance decisions at the plant level.  Escalates when required by procedure, or when potential impact to safety, systemic compliance, customer service or at significant cost.
• Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, design control, and quality systems.
• Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.
• Organizes, plans, leads and manages quality related projects in alignment with company goals.
• Monitors supplier quality related activities to assure fulfillment of contract/purchase order requirements.
• Facilitates the development and training of immediate staff.
• Primary point of contact with all health authorities.
• Cultivates a culture of quality, acting as the voice of Q&C during plant-level interactions. 
• Has a high degree of shop-floor presence (when applicable – might be QA 26 or Lab 26); is visible to employees at all levels of the plant organization as a Q&C leader
• Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions and recommendations in case of QRB and Escalations.
• Identifies, recruits and develops high-performing talent. 
• Ensures a strong pipeline of talent for critical positions. 
• Manages performance of direct reports, and provides input to talent processes for other individuals in the Q&C organization

What we are looking for

Required Qualifications

• Minimum degree in Science / Engineering or related discipline .
• A minimum of ten (10) years of GMP experience (or seven (7) 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 Production

Desired Qualifications

• Master’s Degree in Engineering / Science / Administration (In Supply Chain/Business) considered an asset
• Expert knowledge of cGMP requirements and current Health Authority (i.e. FDA, ANVISA, Health Canada, MHRA) enforcement issues across multiple regulatory classes (Rx, OTC, Cosmetic, Medical Device).
• Demonstrated ability to lead cross-functional local teams, and participate in regional teams to accomplish business objectives, enhance relationships, and inform management to drive change and provide direct feedback.
• Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.

#LI-MA1

Cosa c'è per te

$190,825.00 - $269,400.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.