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Associate Director, Program Lead - Quality Planning & Strategy
Requisition ID: 00001CG7
Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for an Associate Director, Program Lead, Quality Planning & Strategy (QP&S) to be based at any Janssen site worldwide.
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 Lead, QP&S will develop and maintain integrated quality plans for assigned compound development programs, with a focus on Oncology and Hematologic Malignancies. This role supports the company Quality Management System implementation and inspection readiness within Pharma R&D.
Responsibilities will include, but are not limited to:
- Develop and manage integrated quality plans (IQPs) to support business-critical activities (such as health authority submissions to support new molecular entities or new indications for use)
- Work with risk owners across R&D functions to develop effective risk mitigation plans to control risks identified in the IQP
- Provide input to trial oversight and quality strategies to ensure that issues are identified in the IQP and mitigated early.
- Lead quality working groups (QWGs) to define and refine the IQP.
- Organize and lead meetings of the QWG to periodically assess quality metrics to determine if risks are adequately defined and controlled under the IQP.
- Communicate outcomes of QWG meetings to relevant stakeholders, including senior management.
- Lead or assist in the early identification, escalation, and resolution of significant quality issues pose a significant risk to achievement of core company objectives.
- Lead inspection readiness activities to support health authority submissions.
- Develop and execute pre-inspection readiness activities for internal Janssen R&D and external parties that contribute to regulatory submissions.
- May Manage Site Inspections as well as Sponsor Monitor Inspections outside the three major inspectorates (FDA, EMA, MHRA).
- Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy.
- Consult/Collaborate with other BRQC functions to harness the single point of contact model to our business partners
- Ensures that BRQC activities are integrated to maximize BRQC support of submission readiness.
- Collaborates with external development partners for joint clinical quality oversight as per clinical quality agreements
- Provides regular status reports to BioResearch Quality & Compliance (BRQC) management.
- A minimum of a Bachelor’s degree is required. An advanced degree (MD, PhD, MSc, or PharmD) is preferred.
- A minimum of 8 years of relevant experience is required.
- Experience in a Quality, Compliance, and/or R&D environment is preferred.
- Experience in the pharmaceutical industry is preferred.
- Experience with cell therapy or gene therapy is required.
- Experience with CAR-T is preferred.
- Experience in and/or knowledge of risk management in a GCP regulated industry is required.
- Knowledge of the global drug development process, including current GxP regulations, is required, including experience in GCP (Good Clinical Practice).
- Knowledge of FDA/ICH and country-specific regulations and guidelines is required.
- Industry recognized certifications are preferred.
- This position may include up to 10% domestic or international travel as needed.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-Spring House
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Netherlands-North Brabant-Tilburg, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)