Sr. Director Compliance, NA & LATAM

Senior Director Regulatory Compliance, NA & LATAM

Kenvue is currently recruiting for a :

Senior Director Regulatory Compliance, NA & LATAM

Role reports to : Head of Quality, Compliance & Performance

Location : Fort Washington, PA

Travel % : May require up to 25% travel, with higher peaks depending on issues and urgent support needs.

What you will do :

The Sr. Director Regulatory Compliance, NA & LATAM, is responsible for managing and directing the North America, LATAM, and External Manufacturing compliance team members to create and execute the strategy for obtaining sustainable compliance and supporting end-to-end Quality System management across the multiple business units in North America and LATAM, as well as External Manufacturing groups.

This role provides leadership for development, deployment and maintenance of strategic regulatory and quality requirements within North America and LATAM. Lead the core activities of expert cGMP compliance support for sites, while continuing to work closely with other compliance teams, Quality Assurance, and process owners within assigned regions. Will also work closely with key quality, regulatory affairs, supply chain, R&D and compliance partners within the Supply Chain global network, particularly in areas of interest regarding regulatory requirements.

Key Responsibilities :

• Collaborates with the Global Q&C Leadership team members (Make, Source, Commercial Quality and / or Quality Systems) in establishing short- and long-term strategic goals and directs implementation to achieve compliance and business objectives. Participates in and provides inputs to Global management reviews and ensures Site level management reviews are covered by reporting staff.
• Provides support for Q&C initiatives that impact quality and compliance systems, and in partnership with Make and Commercial Quality leadership will develop plans and coordinate resources to support deployment.
• Drives effective business strategies to ensure proactive regulatory compliance programs and projects are standardized and aligned with regulatory requirements, and company standards.
• Provides measurable input into the development and implementation of Regulatory Compliance processes, standards, or plans in support of the organization's strategies, with focus on health authority management and readiness, internal audits, regulatory intelligence and Regulatory Compliance processes.
• Drives the strategy to monitor the implementation and sustainability for compliance remediation projects within assigned regions and functions, as needed. Assures the development and execution of audit plans and provides for the periodic assessment of the overall compliance with the business unit remediation efforts. Monitors quality related data, trends and overall program for sustainability.
• Exercises a high level of independent judgement and execution in anticipating, interpreting, evaluating and resolving complex organizational opportunities while appreciating the direct impact on the operational results of the business. These decisions impact the portfolio and help shape long-term strategies.
• Provides overall management of the Regulatory Compliance staff (direct reports) development and establishes learning initiatives and training of staff in current and emerging regulatory compliance and related requirements.
• Assure the timely execution of the Regulatory Compliance common processes for Independent Audit and Follow-up (CAPA implementation), as well as Recovery.
• This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

What we are looking for :

Required Qualifications :

Education :

Experience :

Desired Qualifications :

Knowledge :

Skills :

Responsibility for Others :

Working Relationships / Interfaces :

What's in it for you :

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit 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.