Director, Quality & Compliance

Director, Quality & Compliance

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

Rollenberichte an:

Sr Director NA MAKE Q and C

Ort:

North America, United States, Pennsylvania, Lititz

Arbeitsort:

Vollständig vor Ort

Was Sie tun werden

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

Was haben Sie davon

$190,825.00 - $269,400.00

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

Kenvue ist stolz darauf, ein Arbeitgeber für Chancengleichheit zu sein. Alle qualifizierten Bewerber werden unabhängig von Rasse, Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, Alter, nationaler Herkunft oder geschütztem Veteranenstatus für eine Beschäftigung in Betracht gezogen und nicht aufgrund von Behinderung diskriminiert.