Johnson & Johnson Careers
Director, Infectious Disease & Vaccine TA Head
Requisition ID: 00001DN3
We are hiring a Director Infectious Disease & Vaccine TA Head lead, within the Quality Planning and Strategy (QP&S), BioResearch Quality & Compliance (BRQC) organization. The position will report to the Senior Director Cross Therapeutic Area Strategy Head.
The Director, Infectious Disease & Vaccine TA Head leads the Quality & Compliance support of the ID&V Therapeutic Areas, within BioResearch Quality & Compliance (BRQC) Janssen. This position is responsible for the development and management of oversight strategies and programs that ensure that issues are identified and mitigated early, such that the functions, processes and systems, and deliverables within clinical R&D are compliant to Health Authority, industry and company standards and regulations.
The individual will provide strategic quality consultation to key stakeholders by developing proactive quality support, real-time issue management, utilizing analytics-based data and therapeutic area expertise. This key position helps set the leadership culture within Quality Planning & Strategy as a strategic business partner.
- Drive the success of the long-term strategic plans for the ID&V therapeutic areas through effective partnering with senior leaders across R&D functions. Provide a holistic and proactive assessment of quality/GCP compliance-related risks that may impact the safety of human subjects enrolled in clinical trials and/or our ability to meet strategic business objectives. Work with cross-functional partners to ensure efficient use of resources to mitigate risks proactively and address issues reactively that are considered significant.
- Oversee the end-to-end quality management of assigned clinical R&D and operations units, including but not limited to proactive risk management, clinical trial issue management, escalation, CAPA oversight, and inspection management. Liaise with BRQC QA to ensure audit plans address significant risks and issues. Liaise with QP&S Vendor Oversight team to ensure appropriate sponsor oversight of any clinical trial-related responsibilities that are delegated to third parties.
- Represent a broad BRQC-driven perspective in key governance meetings where compounds within the TA are discussed. Ensure that risks identified or discussed in these meetings are appropriately captured in risk management activities within the TA.
- Manage a team of QP&S employees to ensure consistent quality oversight of the core business, business continuity, routine process improvement, and effective communication.
- Ensure a close collaboration of those TA QP&S team members with other QP&S functions (L&A, GXP/systems,…) and other BRQC functions (Quality Analytics, Quality Assurance, Quality Management, Quality Management Systems Oversight …) to foster a one-team approach within BRQC and single points of contact for our business partners.
- Serve as a standing member of the QP&S Cross TA Strategy Team
- A minimum of a bachelor’s degree is required; an advanced degree in science or business is preferred.
- A minimum of 7-10 years of related work experience in a medium- to large-scale, matrixed Life Sciences organization is required.
- Demonstrated experience engaging and establishing stakeholder relationships.
- The role requires knowledge of worldwide clinical and preclinical safety compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry.
- Strong personal leadership with demonstrated competency interfacing with leaders
- Strong networking and relationship building skills
- Excellent written and verbal communications skills
- Utilizes and encourages and shares innovative approaches to build and maintain a competitive advantage
- Proficiency with MS Office products (Word, Excel, PowerPoint, Outlook)
- Proficiency with visual aid software
North America, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa
Janssen Pharmaceutica N.V. (7555)