Vice President, Compliance

Johnson & Johnson
Washington, DC
Jul 17, 2017
Jul 17, 2017
Full Time
The Johnson & Johnson Family of Companies is recruiting for a Vice President, Compliance located in New Brunswick, NJ or any J&J location around the globe. Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. With $65 billion in 2011 sales, Johnson & Johnson 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 medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.The VP of Compliance is the senior leader accountable for the Johnson & Johnson Compliance programs across the enterprise spanning the entire product lifecycle. The VP of Compliance will partner with senior leaders within J&J Corporate, Supply Chain and Business organizations to ensure a strong regulatory compliance profile. The VP of Compliance is accountable for providing the regulatory compliance strategy and framework that will improve the overall compliance health of J&J and ensure sustainability. The VP will also provide leadership, oversight, and strategic guidance from an overall enterprise perspective for significant regulatory compliance issues.This leader will work closely with various internal and external stakeholders such as Site & Segment Quality Leaders, Chief Quality Officers, Health Authorities & Industry ExpertsKey Responsibilities include:*Execute an overall Regulatory Compliance Audit Program/ Strategy, the output is used to inform Executive Management, which includes the Executive Committee of Compliance risk to J&J businesses. *Assure operating units are compliant with both regulations and J&J Policy Standards and are promptly responding to problems and implementation of corrective actions.*Responsible for Enterprise Compliance dashboard and reporting preparation for the Johnson & Johnson Compliance Committee, Executive Committee, Board of Directors.*Ensure the coordinated deployment of compliance programs across the business sectors in responses to business-critical compliance issues.*Provide expert consulting in compliance crisis management; inspection readiness and management, directed audits, special investigations, health authority responses and mitigation of systemic compliance risks.*Provide strategic direction for quality systems based on current and emerging regulatory trends, ensure readiness for regulatory inspections, and collaborate across the Enterprise to lead cGMP compliance initiatives and continuous compliance improvement.*Partner with Business and Supply Chain leadership to achieve both strategic and tactical compliance results across the Enterprise.*Provide input for significant enterprise quality and compliance policies.*Assure implementation of both proactive and outcome measures of compliance/compliance profiles at all operating units of all types (R&D, Supply Chain, Distribution, Marketing Company).*Manage the budget and workplan strategies for deploying resources to assure compliance at all levels of J&J.Qualifications*A minimum of a Bachelors degree is required. *A focused degree in science, engineering, or equivalent is strongly preferred.*A minimum of 15 years of experience in Quality and/or Compliance in a global regulated healthcare environment is required. *A minimum of 5 years of experience working inside a Health Authority, Regulatory Agency (ie FDA, MHRA, etc.) is required. Knowledge, Skills and Abilities: *Process Expertise - Has a substantial body of knowledge of processes relevant to quality and compliance of manufacture and production of products in a regulated environment.*Knowledge of regulatory and development process (both pre-approval and post launch monitoring)*Understanding of all Health Authority requirements.*Thorough understanding of how regulatory bodies approach inspections.*Thorough understanding of how to respond to FDA observations. Proven success in:*Developing a high performing team in Quality and Compliance*Creating strong relationships with Regulatory agencies.*Developing working strategic plans in alignment with the enterprise strategic goals.*Creating a future vision and gaining support and alignment to that vision.*Builds interdependent partnerships, acts as the mediator between operating units while optimizing the value proposition.*Regulator experience and reputation and compliance experience.*Experience leading risk-based oversight programs across multiple sectors.*Issue remediation experience.*Bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level and detail*Superior leadership skills. Decisive, organized, and able to lead and develop people within a complex social, cultural and political environment. *Outstanding presence and communication skills, able to inspire trust and quickly build credibility within the Quality and Compliance community, Sr. Executive management, external regulators, and industry.*Strong collaboration skills to partner effectively across Corporate functions and operating units.*Balanced technical understanding of products and processes combined with superior business and compliance acumen.*Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict. *High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others. *Energy, enthusiasm, commitment, courage and entrepreneurial excitement. Must be able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas. *Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Makes the customer central to all thinking.*This position will be based in New Brunswick, New Jersey or any J&J location around the globe and may require up to 25% domestic & internal travel, depending on the location of the role. BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.J2W: LI NAPrimary LocationUnited States-New Jersey-New BrunswickOther LocationsNorth America-United States, Europe/Middle East/Africa-Belgium, Asia Pacific, Latin America, North America, North America-United States-District of Columbia-WashingtonOrganizationJohnson & Johnson Services Inc. (6090)Job FunctionComplianceRequisition ID9163170503