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:

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 consumer, pharmaceutical, and professional markets. J& J employs approximately 126, 500 people worldwide, deployed in more than 250 operating companies in 60 countries. Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, diagnostics, and products relating to family planning, dermatology, and feminine hygiene.

Johnson & Johnson and its subsidiaries have built the most comprehensive base of health care businesses in the world, generating more than 70 per cent of company revenues from No. 1 or No. 2 global leadership positions in their respective markets. Johnson & Johnson’s consistent performance has enabled the company to deliver an exceptional track record of growth that few, if any, companies can claim: 28 consecutive years of adjusted earnings increases and 50 consecutive years of dividend increases.

The company’s worldwide sales for 2020 were $82.5 billion. For the 18th year, Johnson & Johnson was named one of FORTUNE Magazine’s Most Admired Companies for 2020 and was named #1 in the Pharmaceutical category worldwide for the 7th consecutive year. Gartner, Inc., the world’s largest research and advisory company ranked Johnson & Johnson #3 on its annual 2020 Supply Chain Top 25 list which spotlights exemplary global supply chains.

POSITION SUMMARY:

This senior leadership role reports directly to the Vice President of Innovative Medicine Regulatory Compliance and serves as a key member of the Innovative Medicine Regulatory Compliance Leadership Team. It functions as a strategic partner supporting the Chief Quality Officer and is responsible for overseeing regulatory compliance and global remediation initiatives across the entire Supply Chain Network.

The incumbent will be instrumental in advising and executing compliance remediation activities, providing critical insights and updates to senior executives within both the Innovative Medicine division and the Corporate Quality organization. This role involves determining resource requirements, managing project deliverables, coordinating with contractors, and providing overarching oversight for the execution of key compliance programs across large molecule, small molecule, and Contract Manufacturing Organization (CMO) sites managed by the Innovative Medicines Supply Chain organization.

The incumbent is also responsible for guiding and developing cross-functional teams to ensure sustained regulatory compliance. This position interfaces with stakeholders across Quality, Supply Chain, Regulatory Affairs, R& D, and Corporate Johnson & Johnson organizations worldwide.

The role is expected to drive the company’s regulatory compliance strategy, foster operational excellence, promote continuous improvement, and proactively identify and manage quality and compliance risks in a balanced manner that aligns with broader business objectives. The incumbent is accountable for building organizational capabilities that meet both current and future business needs.

MAJOR DUTIES & RESPONSIBILITIES:

• Act as a strategic regulatory compliance advisor and Subject Matter Expert, offering guidance on complex compliance issues across the Supply Chain.

• Lead the proactive identification, assessment, and prioritization of risks associated with remediation initiatives, ensuring effective risk management in collaboration with IM leadership.

• Partner with key stakeholders to escalate critical compliance risks to senior management, facilitating informed decision-making at the highest levels.

• Provide visionary compliance leadership and insights to inform the development of comprehensive, global risk mitigation strategies.

• Design and oversee the implementation of robust compliance remediation programs that adhere to all voluntary, regulatory, and statutory requirements, ensuring organizational adherence and risk reduction.

• Shape and execute both short-term objectives and long-term remediation strategies, ensuring alignment with organizational goals and regulatory requirements.

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

• Advanced Degree preferred

Preferred Knowledge, Skills and Abilities:

• Project Management

• Large Molecule

• 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

The anticipated base pay range for this position is:

173, 000 --- 299, 000 USD 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.