Director, Site Regulatory Compliance

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality & Compliance Audit

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Director, Site Regulatory Compliance to be located in Raritan, NJ; Horsham, PA or Malvern, PA.

Purpose:

The Director, Regulatory Compliance is the senior Site-Based Compliance leader responsible for providing independent compliance leadership, maintaining visibility of the site compliance-risk posture, promoting continuous inspection readiness, enabling timely escalation, and strengthening organizational learning at an Advanced Therapy manufacturing site.

The role serves as a strategic compliance partner to Site Leadership, Quality, Manufacturing, MSAT, Engineering, Supply Chain, Regulatory Affairs, and Quality Control.

The Director brings an independent regulatory compliance perspective to significant risks and decisions and helps connect site signals to platform and enterprise priorities.

The role requires deep knowledge of advanced therapy manufacturing and the regulatory and operational risks associated with autologous and allogeneic cell therapies, chain of identity, chain of custody, aseptic processing, manufacturing execution systems, cryopreservation, cellular starting materials, and patient-specific manufacturing operations.

As a people leader, the Director builds and develops a high-performing compliance organization and strengthens compliance capability across the site.

The Director enables the site to maintain a sustained state of compliance and inspection readines...