Computer System Validation and Laboratory Compliance Lead NA

Description

Kenvue is currently recruiting for a:

Computer System Validation and Laboratory Compliance Lead NA

What we do

At Kenvue , we realize the extraordinary power of everyday care.

Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love.

Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.

We are passionate about insights, innovation and committed to delivering the best products to our customers.

With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day.

We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours.

For more information , click here .

Role reports to:
Senior Director Auditing

Location:
North America, United States, Pennsylvania, Fort Washington

Work Location:
Fully Remote

What you will do

Responsible for:

• Establishing and executing the regulatory compliance strategy and operational excellence for Technology Services and Technology Quality and Compliance.

• Supporting the execution of the corporate's Regulatory Compliance audit program serving as a CSV (computer system validation) and Laboratory SME, across Internal Manufacturing (IM), External Manufacturing (EM), suppliers and others to assure audit readiness and compliance with applicable government regulations, company standards, policies, quality agreements, international standards and procedures.

• Identifying, accurately capturing holistic view of potential compliance risks, documenting audit findings and promptly communicating, and as appropriate escalating issues to senior management.

• Issuing and distributing, in a timely manner, audit results for review by management and

• Developing and maintaining effective and collaborative business relationship with key stakeholders and functional department within Kenvue to ensure that the strategic objectives of the corporate audit program are achieved and continuously improving execution and results based on process insights.

• Support execution of supplier audits managed by Technology and Compliance.

• Performing Assessment of CSV and Laboratories as part of execution of the Quality Maturity Model.

• Providing subject matter expertise to Technology groups, global laboratories and other business partners.

• Developing compliance strategies that meet regulatory requirements, while enabling innovation.

• Identification of Risk themes resulting from audit observation analysis performed by Regulatory Compliance or Technical Quality & Compliance.

• Partnering with Technology Services, Technical Quality & Compliance, Digital Strategy Qual...