Lead CSV Specialist - NA

Kenvue•Summit, NJ

8d•Hybrid

About The Position

Technology Quality and Compliance (TQ&C) manages the quality and compliance strategy for technology systems including applications, infrastructure, and digital health solutions. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with the company’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with addressing compliance gaps related to audits and inspections. The Lead Computer Systems Validation Specialist (CSV) NA is responsible for the building and execution of quality into enterprise wide systems, tools, services, and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, and retire).

Requirements

Bachelor's degree or equivalent in Business, Marketing, Data Science, or a related field.
4 to 6 years of experience in customer success, value management, process validation, equipment qualification, or related quality assurance roles.
Strong knowledge of industry regulations, validation policies, and quality systems.
Proven ability to analyze technical problems and implement corrective actions.
Experience in developing and reviewing validation and qualification documentation.
Excellent communication skills for effective collaboration with cross-functional teams and external parties.

Nice To Haves

Proven expertise in leveraging analytics tools and CRM platforms to drive customer insights and strategic decision-making.
Exceptional communication skills with the ability to translate complex data into compelling narratives for diverse stakeholders.
Demonstrated leadership capabilities with a track record of mentoring teams and driving cross-functional collaboration.
Capability to lead validation activities and represent the function during audits and inspections.
A proactive mindset with a passion for innovation, continuously seeking novel approaches to enhance customer value and business growth.

Responsibilities

Engaging with technology team members ensuring early involvement of TQ&C in the design and development of applications and infrastructure, building quality into the work product, and controls within the application/solution while leveraging automation whenever feasible.
Ensuring company quality standards and regulatory requirements are met for the systems under the scope of responsibility.
Planning, executing, coordinating, and maintaining the validation activities for the systems within their scope, including approval of SDLC validation documentation, release system implementation, and/or changes for production use while providing computerized systems validation guidance and support to support team members in the execution of system base business activities, enhancements, and small projects.
Reviewing and approving SOPs and WIs related to the systems within their scope and assisting with incident management/CAPA (Corrective and Preventative Action) and NCs for systems supported.
Supporting internal audits, Health Authority regulatory inspections, and system periodic reviews.