J&J Family of Companies Associate Director, BioResearch Regulatory Compliance in Lansing, Michigan
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.
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.
• Responsible for providing expert strategy, direction, and advice to business partners related to global GxP regulatory requirements.
• Responsible for contributing to the strategic design and implementation of an effective and proactive inspection readiness and management framework to optimally prepare and support inspections.
• Responsible for leading the coordination of inspection preparation, conduct and post-inspection activities.
• Responsible 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.
• Responsible for providing independent and expert strategic direction and advice for Regulatory Authority communications.
• Responsible 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
• Responsible for executing a GXP mock inspection program that proactively identifies areas of inspection risk and tests R&D’s level of inspection readiness
• Responsible for leading the conduct or coordination of special investigations
• Responsible for supporting Business Partners through significant compliance remediation activities, providing expert regulatory compliance advice and solutions
• Responsible for external influencing, working with the regulators, defining key strategies for influencing with global Health Authorities.
• Responsible 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
• Ensures key business partners and corporate compliance partners are advised of critical compliance issues that relate to Regulatory Authority activity.
• Provides strategic leadership, coaching, and mentoring to business partners colleagues
• A minimum of a Bachelors degree is required. Masters in related field or other advanced degree is preferred.
• A minimum of 8 years of experience in a regulated industry is required.
• 3 plus years of experience and demonstrated leadership in a quality function working on complex and significant compliance topics is preferred.
• Demonstrated experience with GCP compliance is required.
• Comprehensive knowledge of worldwide GLP, PV, and IT compliance regulations and guidelines is preferred.
• Knowledge of latest auditing, investigation and remediation techniques as well as leadership experience with inspections is preferred.
• Demonstrated effective influencing, interpersonal, written and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations is required.
• Experience with Regulatory Authorities is preferred.
• Experience working with device, diagnostic and cosmetic product classifications (in addition to pharmaceuticals) is preferred.
• Experience with associated compliance systems such as GMP and HCC is preferred.
• Travel requirements: approx. 10-20% global travel will be required
United States-New Jersey-Titusville-
North America-United States, Europe/Middle East/Africa-France-Île-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
Janssen Research & Development, LLC. (6084)