Innovative Medicine Regulatory Compliance HEAD

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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COMPANY BACKGROUND& CULTURE
Johnson & Johnson (J&J) is the worlds 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 126500 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 & Johnsons 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 companys worldwide sales for 2020 were $82.5 billion. For the 18th year Johnson & Johnson was named one of FORTUNE Magazines Most Admired Companies for 2020 and was named #1 in the Pharmaceutical category worldwide for the 7th consecutive year. Gartner Inc. the worlds 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 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.

MAJOR DUTIES & RESPONSIBILITIES

• 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

REQUIRED QUALIFICATIONS

Required Minimum Education: Bachelors 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: Masters 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 () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :