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POSITION SUMMARY

This position reports to the Vice President Innovative Medicine Regulatory Compliance and will oversee a team of 15+ people and will serve as a key member of the Innovative Medicine Regulatory Compliance Leadership Team. They are accountable for regulatory compliance within the Large Molecule and Small Molecule Platforms, including compliance oversight and execution of key compliance programs for large molecule, small molecule and CMO sites managed by the Innovative medicines Supply Chain organization. The Head is responsible to lead a team(s) of compliance professionals to establish, maintain and continually improve a robust compliance program that drives proactive and sustained compliance. The Head connects with the Quality, Supply Chain, Reg Affairs, R&D, and Corporate J&J stakeholders across the Global organization. The position is expected to drive regulatory compliance strategy, operational excellence, continuous improvement and to identify and provide balanced management of quality and compliance risks with business needs. The Head is accountable for organizational depth to meet present and future business needs.

REQUIRED QUALIFICATIONS

Required Minimum Education: Bachelor’s Degree in Science or related field
Required Years of Related Experience: 15+ years of experience in Quality Assurance, Operations, Engineering, and/or Regulatory Compliance

Required Knowledge, Skills and Abilities:

• Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context.
• Experience working in the Pharmaceutical regulated healthcare environment.
• Detailed knowledge of Pharmaceutical sector regulatory requirements.
• Understands the interrelationship among all Quality functions and with other business areas.
• Experience working with, or for, any Regulatory Agencies or Health Authorities (i.e., US FDA, MHRA, etc.)
• Demonstrated track record of achieving successful compliance outcomes, remediating compliance issues and supporting regulatory agency inspections.
• Demonstrated ability to develop and maintain strong relationships with Regulatory agencies.
• Ability to build partnerships, manage complexity and mediate issues, while optimizing the value proposition.
• 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.
• Strong analytical skills and experience implementing risk-based oversight programs across multiple businesses.
• Strong executive presentation skills.
• Demonstrated 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.
• Strong compliance reputation and large-scale quality management system experience.

People Management Experience: At least 10 years is required

PREFERRED QUALIFICATIONS

Preferred Minimum Education: Master’s Degree

Preferred Related Industry Experience:

• Have direct experience supporting a company under consent decree by the FDA
• Previous experience working inside a regulatory agency (e.g. FDA, MHRA, etc)
• Advanced Degree preferred

Preferred Knowledge, Skills and Abilities:

• Large Molecules
• Advanced Therapies
• Small Molecule

Travel on the Job: Yes, up to 40% domestically and internationally
WORK LOCATION: Raritan, NJ; Horsham, PA; Titusville, NJ - the position may not be performed remotely
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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

• Act as a senior regulatory compliance strategist and Subject Matter Expert, providing authoritative guidance on complex compliance issues across the Pharma Platforms.
• Lead the proactive identification, assessment, and prioritization of compliance risks, ensuring effective mitigation aligned with overall business objectives.
• Partner with senior level stakeholders to escalate critical compliance risks and facilitate informed decision-making at the highest levels.
• Provide strategic compliance insights and a global perspective to shape risk mitigation frameworks and strategies.
• Design and oversee comprehensive compliance programs that meet or exceed all voluntary, regulatory, and statutory standards.
• Monitor and communicate emerging external regulatory trends and compliance challenges, advising on their impact and necessary actions.
• Develop and drive both short-term milestones and long-term strategic plans, ensuring alignment with organizational objectives and maximization of stakeholder value.
• Foster a culture of high performance and continuous improvement, leveraging key performance metrics, industry benchmarking, and best practice sharing to elevate compliance standards