Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for a Director, Quality Planning & Strategy (Pharmacovigilance Leader) to be based at one of the following sites: Raritan, NJ; Titusville, NJ; Springhouse, PA; High Wycombe, UK; Beerse, BE; or Leiden, NL.
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 Director, Quality Planning & Strategy (Pharmacovigilance Leader) will enable corporate R&D objectives through risk management and quality planning across the Pharma PV space by partnering with relevant business partners. Under the general direction of the Head, GxP Systems Strategy, QP&S the PV Strategy Lead is responsible for the development and execution of a quality framework to proactively identify and mitigate system and portfolio risks and mitigate significant quality issues that may have an impact on approval or acceptance of health authority submissions, licence status and/or general compliance to company and industry standards; national and international regulations.
The Director, Quality Planning & Strategy (Pharmacovigilance Leader) will:
- Manage the development of PV (Pharmacovigilance) integrated quality plans (IQPs) to continuously assess risk to business-critical activities (e.g. maintenance of the Pharmacovigilance System Master File, PV system inspections of Janssen R&D, health authority submissions to support new molecular entities or new indications for use, maintenance of licences and co-licencing, etc.).
- Work with risk owners across R&D PV functions to develop effective risk mitigation plans to control risks identified in the IQPs.
- Ensure BRQC Janssen activities are integrated to maximize BRQC Janssen support of readiness for PV inspections.
- Organize and lead meetings with key PV business leaders to periodically assess quality metrics and determine if risks are adequately defined and controlled under the IQPs. Communicate outcomes from meetings to relevant stakeholders, including senior management.
- Lead or assist in the early identification, escalation, and resolution of quality issues that pose a significant risk to achievement of core company PV objectives.
- In collaboration with Regulatory Compliance, lead inspection readiness activities to support health authority inspections of PV systems. Develop and execute pre-inspection readiness activities for internal Janssen R&D and external parties that contribute to inspection preparation.
- Provide input into portfolio oversight and audit strategies as needed to ensure that PV issues identified from ongoing surveillance are built into risk mitigation plans in the IQPs.
- Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy.
- A minimum of a Bachelor of Science (BSc) degree in a life science, natural science or business is required
- An advanced degree (MD, PhD, MSc, or PharmD) is desirable
- A minimum of 12 years of experience in a GxP regulated discipline with at least 3 years in Pharmacovigilance operations and/or medical safety is required
- Experience in a GxP quality role is preferred
- Experience in and/or knowledge of risk management in a regulated industry is required
- Recognized professional certifications (CRM, RMP, etc.) are preferred
- Knowledge of the global drug development process, including current global PV regulations, is required
- Ability to drive results through credibility, influence and leadership by example is required
- Strong networking and relationship building skills are required
- Ability to lead a team and operate in a matrix organization is required
- This position will be based in Raritan, NJ; Titusville, NJ; Springhouse, PA; High Wycombe, UK; Beerse, BE; or Leiden, NL
- This position may require up to 25% domestic and international travel depending on business needs
United States-Pennsylvania-Spring HouseOther Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function