4 days old

Associate Director, BioResearch Regulatory Compliance

Johnson & Johnson
Hopewell Township, NJ 08560

The Johnson and Johnson Family of Companies is recruiting for an Associate Director, BioResearch Regulatory Compliance to be located at any J&J site in the United States or Europe.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $76.5 billion in 2017 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 markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Summary:
This Associate Director, BioResearch Regulatory Compliance is responsible for providing expert strategy, direction, and advice to business partners related to GxP regulatory requirements. This position will contribute to the strategic design and implementation of an effective and proactive inspection readiness and management framework to optimally prepare and support inspections. This involves providing expert GxP strategic direction before, during and after inspections (including strategic direction for communication with Regulatory Authorities). The incumbent will also be responsible for monitoring (mining) external industry and internal J&J inspection outcomes and trends, ensuring this information is proactively shared with Business partners and effectively used to shape the Regulatory Compliance mock inspection program. In addition, this position is responsible for the execution of all Regulatory Compliance activities.

The incumbent reinforces the message that compliance and quality have a high company priority and assures effective implementation of R&D compliance audit programs. This is a key global cross functional strategic role that drives enhanced compliance across R&D. The incumbent will manage company-wide complex compliance issues interfacing with senior leadership on an ongoing basis. Decisions made at this level will have far reaching compliance consequences across the pharmaceutical sector and other sectors as appropriate.

Responsibilities:
*\tResponsible for providing expert strategy, direction, and advice to business partners related to global GxP regulatory requirements.
*\tResponsible for contributing to the strategic design and implementation of an effective and proactive inspection readiness and management framework to optimally prepare and support inspections.
*\tResponsible for leading the coordination of inspection preparation, conduct and post-inspection activities.
*\tResponsible for providing strategic direction for communication with Regulatory Authorities post inspection, including the Regulatory Compliance review and input to inspection observation responses prior to submission and the oversight of inspection commitments ensuring documented evidence of completion.
*\tResponsible for providing independent and expert strategic direction and advice for Regulatory Authority communications.
*\tResponsible for ongoing monitoring (mining) of external industry and internal J&J inspection outcomes and trends, ensuring this information is proactively shared within Business partners and effectively used to shape the Regulatory Compliance mock inspection program
*\tResponsible for executing a GXP mock inspection program that proactively identifies areas of inspection risk and tests R&D’s level of inspection readiness
*\tResponsible for leading the conduct or coordination of special investigations
*\tResponsible for supporting Business Partners through significant compliance remediation activities, providing expert regulatory compliance advice and solutions
*\tResponsible for external influencing, working with the regulators, defining key strategies for influencing with global Health Authorities.
*\tResponsible for contributing to an effective quality and compliance regulatory Intelligence operation by monitoring global/regional/local regulatory requirements and supporting internal impact assessments for new/changing requirements
*\tEnsures key business partners and corporate compliance partners are advised of critical compliance issues that relate to Regulatory Authority activity.
*\tProvides strategic leadership, coaching, and mentoring to business partners colleagues

Qualifications
*\tA minimum of a Bachelors degree is required. Masters in related field or other advanced degree is preferred.
*\tA minimum of 8 years of experience in a regulated industry is required.
*\t3 plus years of experience and demonstrated leadership in a quality function working on complex and significant compliance topics is preferred.
*\tDemonstrated experience with GCP compliance is required.
*\tComprehensive knowledge of worldwide GLP, PV, and IT compliance regulations and guidelines is preferred.
*\tKnowledge of latest auditing, investigation and remediation techniques as well as leadership experience with inspections is preferred.
*\tDemonstrated effective influencing, interpersonal, written and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations is required.
*\tExperience with Regulatory Authorities is preferred.
*\tExperience working with device, diagnostic and cosmetic product classifications (in addition to pharmaceuticals) is preferred.
*\tExperience with associated compliance systems such as GMP and HCC is preferred.
*\tTravel requirements: approx. 10-20% global travel will be required

Primary Location
United States-New Jersey-Titusville-
Other Locations
North America-United States, Europe/Middle East/Africa-France-ÃŽle-de-France-Paris, Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Switzerland-Schaffhausen-Schaffhausen
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
00001E4Q
Posted: 2019-01-11 Expires: 2019-02-10

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Associate Director, BioResearch Regulatory Compliance

Johnson & Johnson
Hopewell Township, NJ 08560

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