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 https://www.jnj.com

Job Function:
Legal & Compliance

Job Sub Function:
Enterprise Compliance

Job Category:
People Leader

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

Job Description:

Innovative Medicine, Regulatory Compliance, Large Molecule/Advanced Therapies Leader

COMPANY BACKGROUND& CULTURE
Johnson & Johnson (J&J) is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the pharmaceutical, and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries.

Johnson & Johnson, Innovative Medicine a leading pharmaceutical company under Johnson & Johnson, has established a strong presence in the field of biologics and large molecule therapies, particularly through its innovative advanced therapies portfolio. The company's contributions have significantly advanced the treatment landscape for various complex diseases, including oncology, immunology, and rare genetic disorders. Janssen's biologics are known for their targeted mechanisms of action, which offer improved efficacy and reduced side effects compared to traditional therapies. Their focus on cutting-edge technologies such as gene therapy, cell therapy, and monoclonal antibodies has positioned them at the forefront of personalized medicine, providing new hope to patients with previously untreatable conditions. Overall, Janssen's commitment to innovation and scientific excellence continues to drive meaningful improvements in patient outcomes, shaping the future of medicine and expanding the possibilities for addressing some of the most challenging health issues worldwide.

POSITION SUMMARY

This compliance leadership role reports to the Vice President, Innovative Medicine Regulatory Compliance Leader, and oversees a team of 15+ compliance professionals as part of the Leadership Team. The position is responsible for regulatory compliance within the Large Molecule and Advanced Therapies Platforms, including Health Authority Inspection readiness and site audits. Key duties include leading and developing the compliance team, maintaining a robust program, and collaborating closely with Quality, Supply Chain, Regulatory Affairs, R&D, and Corporate Compliance partners to support current and future business needs.

MAJOR DUTIES & RESPONSIBILITIES

• Serve as an expert regulatory compliance advisor and Subject Matter Expert across the Large Molecule and Advanced Therapies Platforms
• Provide compliance expertise and global compliance perspective in the development of preventive risk management strategies.
• Proactively identify and prioritize risks and provide guidance on the management of those risks while balancing business needs.
• Partner with stakeholders to escalate critical risks to the appropriate levels of management.
• Execute compliance programs such as Internal Audit and Inspection Readiness activities to ensure platform compliance with internal and external regulatory and statutory standards.
• Communicate emerging regulatory compliance issues and trends.
• Develop and achieve short term targets and longer-term compliance strategies.
• Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices

REQUIRED QUALIFICATIONS
Required Minimum Education: Bachelor's Degree
Required Years of Related Experience: Either combined or separately, 20+ years of experience in Pharmaceutical or Medical Device Quality Assurance or Quality Operation and/or Regulatory Compliance; or as an Investigator in the US FDA

People Management Experience: 10+ years is required

Required Knowledge, Skills and Abilities:

• Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context.
• Experience and knowledge of working in the Pharmaceutical regulated healthcare environment.
• Experience working with, or for, any Regulatory Agencies or Health Authorities (i.e., US FDA, MHRA, etc.)
• Track record of achieving successful compliance outcomes, remediating compliance issues and supporting regulatory agency inspections.
• Ability to build partnerships, manage complexity and mediate issues
• Through influential leadership, having the ability to build consensus and impact outcomes without always having line authority; able to negotiate trade off decisions across the organizations in the company.
• Experience implementing or managing risk-based oversight programs across multiple businesses.
• Executive presentation skills.
• Track record of leading direct and indirect teams to deliver results.
• Ability to balance technical understanding of products and processes with compliance perspective and business acumen.

PREFERRED QUALIFICATIONS
Preferred Minimum Education: Bachelor's Degree

Preferred Related Industry Experience:

• Have direct experience supporting a company under FDA Warning Letter or Consent decree
• Previous experience working inside a regulatory agency (e.g. FDA, MHRA, etc)

Preferred Knowledge, Skills and Abilities:

• Large Molecules
• Advanced Therapies

Travel on the Job: Up to 40% domestically and internationally

Work Location: Raritan, NJ; Horsham, PA; Titusville, NJ - the position may not be performed remotely

The anticipated base pay range for this position is :
173,000 --- 299,000 USA Annual

Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.