External Manufacturing Compliance Principal

Janssen Supply Group, LLC.

is recruiting for an External Manufacturing Compliance Principal to be located in New Brunswick, NJ, Raritan, NJ, Horsham, PA or near any Johnson and Johnson Innovative Medicine site in the United States.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

The Compliance Principal is accountable for regulatory compliance oversight of External Manufacturers within the J&J External Supply Chain.

The Compliance Principal is responsible for the execution of key compliance programs to drive proactive and sustained compliance that enable delivery of business objectives.

This individual serves as a global resource and provides expert cGMP/GXP compliance oversight for J&J's external supply chain.

This is inclusive of External Manufacturers and Suppliers regulated by international health authorities and regulatory agencies.

They will provide compliance subject matter expertise for significant investigations, inspections, and projects that span the external supply chain.

The Compliance Principal partners closely with External Quality leadership to assure compliance programs are implemented and maintained.

They will collaborate with cross functional partners to prepare, manage, and respond to health authority inspections at external manufacturing sites, support external manufacturer qualification activities, and due diligence assessments.

Responsibilities:


* Serve as an experienced regulatory compliance advisor and Subject Matter Expert on key strategic and critical compliance issues.


* Understand site risk profiles and proactively identify and prioritize risks.

Partner with stakeholders to escalate critical risks to the appropriate levels of management.

Provide compliance expertise and global compliance perspective in th...