Director, Site Regulatory Compliance Advanced Therapy

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 as a Director, Site Regulatory Compliance Advanced Therapy (AT), 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 readiness by providing proactive and independent compliance leadership, strengthening risk visibility, enabling effective governance and escalation, and fostering prevention, transparency, and continuous improvement.

Key Responsibilities:

• Provide strategic site compliance leadership and independent regulatory compliance perspective on site inspection readiness and regulatory risk, product launch readiness and technology transfers, capacity expansion and facility modifications, major deviations, quality events, and data integrity concerns. Provide input on supply continuity risks and enterprise compliance initiatives and potential regulatory reporting events, without assuming formal reportability decision ownership.
• Drive enterprise thinking and organizational capability to connect significant site risks to platform and enterprise risks, promote consistent risk identification, escalation, and cross-site learning. Support implementation of enterprise compliance priorities and transformation initiatives, develop strong compliance talent and coach leaders on risk-based decision-making and strengthen inspection-readiness capability and a culture of transparency and accountability.
• Provide an independent regulatory compliance perspective on the site compliance-risk posture and support effective visibility, prioritization, escalation, and governance of significant risks. Relevant risk areas may include advanced therapy operations, aseptic processing, environmental monitoring, chain of identity and custody, manufacturing execution systems, data integrity, validation, technology transfer, facility and equipment controls, regulatory commitments, and supply continuity.
• Provide independent oversight of continuous inspection readiness in partnership with Site Quality and accountable functions. Advanced Therapy focus areas include aseptic manufacturing, autologous and allogeneic operations, chain of identity and custody, patient-specific process controls, manufacturing execution systems, cryogenic storage and transportation, comparability, multi-site lifecycle controls, and electronic records.
• Provide compliance leadership for Advanced Therapy manufacturing operations.
• Lead, coach, and develop Site-Based Regulatory Compliance staff.
• Develop succession plans and foster an inclusive, accountable, and high-performing culture.

Qualifications/Requirements:

• Bachelor’s degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Microbiology, Chemistry, or related scientific discipline is required.  Advanced degree preferred.
• 10+ years of pharmaceutical or biotechnology experience.
• 5+ years of leadership experience.
• Significant experience in biologics manufacturing operations, quality, compliance, or regulatory oversight.
• Experience supporting FDA, EMA, MHRA, or PMDA inspections and other global health authority inspections.
• Knowledge of cell therapy manufacturing, including autologous and allogeneic operations.
• Knowledge of GMP regulations and Advanced Therapy regulatory expectations.
• Knowledge of chain of identity and chain of custody controls.
• Knowledge of aseptic processing, data integrity, process validation, and quality systems.
• Knowledge of inspection readiness, regulatory risk assessment, governance, escalation, and organizational learning.
• Strong communication, influencing, people-leadership, and cross-functional partnership skills.
• This position may require from 10% to 25% domestic and/or international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Developing Others, Inclusive Leadership, Leadership, Managing Managers, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Management, Stakeholder Management, Tactical Planning, Third-Party Auditing

 

 

The anticipated base pay range for this position is :

$150,000.00 - $258,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits