Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for an Associate Director, BioResearch Regulatory Compliance to be based at a J&J Operating company in the Northeast US. Preferred locations include Raritan or Titusville, NJ; Spring House or Horsham, PA. Considerations will be made for other J&J operating sites.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Associate Director, BioResearch Regulatory Compliance will:
- Provide expert strategy, direction, and advice to BRQC and business partners related to GxP regulatory requirements.
- 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).
- Be 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.
- Execute a GXP mock inspection program that proactively identifies areas of inspection risk and tests R&D’s level of inspection readiness.
- Perform routine periodic audits of BRQC functions providing assurance that internal BRQC processes are compliant with internal and external requirements.
- Support BRQC/Business Partners through significant compliance remediation activities, providing expert regulatory compliance advice and solutions.
- Be responsible for monitoring (mining) external industry and internal J&J inspection outcomes and trends, ensuring this information is proactively shared within BRQC and Business partners and effectively used to shape the Regulatory Compliance mock inspection program.
- Manage companywide complex compliance issues interfacing with senior leadership on an ongoing basis.
- Be responsible for external influencing, working with the regulators, defining key strategies for influencing with global Health Authorities.
- Contribute 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.
- A minimum of a Bachelor’s degree (or equivalent degree) is required.
- A Master’s degree in a related field or other advanced degree is desirable.
- A minimum of 10 years of relevant experience with at least 3 years’ of leadership/management experience in the Pharmaceutical, Medical Device and/or Consumer/OTC industry working on complex and significant GxP compliance topics is required.
- Knowledge of inspection readiness programs/processes is required.
- Strong knowledge of Medical Device regulations is preferred.
- Experience working with diagnostic and/or cosmetic product classifications is desirable.
- Comprehensive working knowledge of at least one of the following areas is required: worldwide GCP, GLP, and/or PV (Pharmacovigilance) compliance regulations.
- Must be capable and resourceful in the use and navigation of current/emerging technology/tools to further the Regulatory Intelligence program.
- Must be capable of navigating and analyzing high volumes of information.
- Knowledge of latest auditing, investigation and remediation techniques is preferred.
- Experience working directly with Regulatory/Health Authorities is preferred.
- Fluency (both oral and written) in English is required. Fluent means that you are completely comfortable communicating on a detailed, professional level.
- The preferred location for this position is at a J&J Operating company in the Northeast US. Preferred US locations included Raritan or Titusville, NJ; Spring House or Horsham, PA. Considerations will be made for other J&J operating sites.
- Position may require up to 20-30% domestic/international travel depending on business needs.
United States-New Jersey-RaritanOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-HorshamOrganization
Janssen Research & Development, LLC. (6084)Job Function