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, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
Essential Job Duties and Responsibilities:
The VP, Innovative Medicine Regulatory Compliance position reports into the VP of J&J Regulatory Compliance. This role oversees all aspects of regulatory compliance within Innovative Medicine, ensuring the company's adherence to all applicable regulations, managing internal audits and maintaining a high state of readiness for regulatory inspections. This involves developing and implementing strategic compliance plans, managing regulatory interactions, and building a robust compliance culture within the organization. The position requires extensive communication with key stakeholders, health authorities, suppliers and other functional leaders. This role will provide executive leadership for compliance teams including internal audits. The VP will develop and implement strategies for new compliance programs and ensure effective regulatory performance. The VP will engage with internal leaders and manage a team of 60+ professionals. This leader should bring an understanding of supply chain strategy and manage key relationships to deliver on strategy. This position must shape, connect, and lead resources to identify and resolve key compliance challenges.
Main Duties/Additional Duties/Sphere of authority
* Oversee the development and execution of Innovative Medicine regulatory compliance strategies, ensuring compliance with FDA, EMA, and other relevant global regulatory agencies.
* Applies deep understanding of compliance excellence to identify issues; partners with relevant health authorities, supply chain leaders, and external parties to deliver improvements and resolutions while striving for continuous improvement.
* Lead and oversee all aspects of inspection readiness, including developing and implementing inspection readiness programs, managing the response to inspection findings, and ensuring that all documentation is up-to-date and readily accessible.
* Is a key partner to Innovative Medicine leadership teams. Helps shape strategy and prioritize innovation to impact the overall organization.
* Develops the vision, strategy and implementation plans for progressive compliance initiatives.
* Understands relevant laws and regulations for the business and engages in strategic planning and partnering to ensure alignment across leadership teams.
* Ability to communicate complex compliance and audit issues across matrixed manufacturing and supply chain business segments.
* Connects directly with internal teams to establish risk management strategies and other external parties to assure alignment of J&J’s objectives, including quality, reliability and innovation.
* Develop and maintain regulatory outreach partnering with industry groups and regulators to understand the regulatory environment and help shape future policy
* Builds a high-performing team culture with strong focus on business integration and a continuous improvement mindset to achieve year-over-year improvements.
* Partners with Supply Chain, Quality and External Supply to deliver on compliance excellence.
* Builds and maintains relationships throughout J&J that foster dynamic, interactive dialogue on a broad range of perspectives and information critical to developing optimal approaches and solutions.
* Identifies, develops, and directs the implementation of compliance goals and risk strategies while incorporating strong governance practices to ensure cross-functional alignment.
* Delivers on regulatory, compliance, quality audit, budget and growth commitments.
* Connects with industry groups and other supply chain leaders to assure alignment of JNJ’s objectives, including quality, reliability, innovation, and cost.
Minimum Qualification:
* US FDA investigative experience preferred
* Bachelor’s degree in engineering, science, or an equivalent technical discipline
* 15+ years working in US FDA regulated environments
* 10+ years of people leadership experience leading large, complex teams
* Detailed knowledge of current Good Manufacturing Practices
* A proven ability to prepare for and manage inspections, including conducting mock inspections and providing training to relevant functions
* Excellent leadership skills, self-starting/-motivated with highly developed interpersonal and teamwork skills
* Ability to quickly process and communicate complex information and make critical decisions with limited information
* Experience influencing or persuading others to accept new ideas, approaches, or concepts or gains alignment on divergent issues with limited guidance.
* Experience with Quality processes and procedures and systems
* Is viewed as a trusted partner across the business, anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances.
* Big picture orientation with attention to detail and results oriented are required.
* Ability to work in a matrix and multi-cultural environment required.
* Proficient in written and spoken English is required.
Other requirements:
* Available for travel (up to 35%) Domestic and international.
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.
The anticipated base pay range for this position is :
$194,000 --- $356,500 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. #J-18808-Ljbffr