Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for a Program Manager, BRQC Regulatory Compliance (Regulatory Intelligence) with the preferred location of a J&J Operating company in Europe or 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.
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 Program Manager, BRQC Regulatory Compliance (Regulatory Intelligence) will:
- Support the strategic execution and maintenance of the BRQC (Bio Research Quality & Compliance) Regulatory Intelligence program.
- Develop an effective and coordinated BRQC approach to monitoring, evaluating and facilitating the implementation of new or revised regulatory requirements/guidance’s, as well as, enabling BRQC and business functions by providing current trends in industry and company compliance.
- Also support the strategic execution of other BRQC Regulatory Compliance activities including, inspections, special investigations, internal audits, support for ERC audits, compliance remediation, etc.
- Be responsible for daily monitoring (Mining) of external industry regulatory intelligence information for GxP and business sector applicability, as well as, internal J&J inspection outcomes and trends.
- Includes coordination of internal searches to identify applicability within business functions.
- Provide results to respective Quality and Compliance organizations to facilitate any assessment of potential impact.
- Lead and support commenting opportunities associated with draft regulations/guidance relevant to GxP business support areas.
- Work closely with BRQC and business functions, as well as, applicable Regulatory Affairs and external outreach functions (e.g. GRPI, ERO) to enable and solicit commenting. Responsible for compiling comments and providing an aligned position to contribute further in the commenting process.
- Handle identification (Monitoring) of new or revised regulatory requirements with the potential to impact relevant to GxP scope of BRQC and respective business areas. This will includes tracking of monitoring activities as well as completion of an initial high level impact assessment communicated to potentially impacted functions.
- Be responsible for the development of metrics and material content for presentation of Regulatory Intelligence topics. This includes key external trends and HA inspection outcomes for presentation at various forums and management meetings for the purpose of ensuring awareness of current status and sharing of information.
- 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 8 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.
- 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 Europe or 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
Europe/Middle East/Africa-Belgium, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-Netherlands, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom, North America-United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function