The Senior Director, Cross TA Strategy Lead - BioResearch Quality & Compliance is the leader of the quality therapeutic areas (CVM, IDV, NS, GPH and Immunology) department reporting to the Head of the Quality Planning & Strategy (QP&S) department within BioResearch Quality & Compliance (BRQC) Janssen.
Responsibilities will include, but are not limited to:
- Drive the success of the long-term strategic plans for the R&D therapeutic area through effective partnering with 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.
- Lead the clinical R&D and operations units across the applicable TAs, including but not limited to proactive risk management, clinical trial issue management, escalation, CAPA oversight, and inspection management. Liaise with BRQC Janssen QA to ensure audit plans address significant risks and issues.
- Represent a broad BRQC Janssen driven (and holistic) perspective in key governance meetings where compounds within the TAs are discussed.
- Ensure that risks identified or discussed in these meetings are appropriately captured in risk management.
- Manage a team of QP&S employees to ensure consistent quality oversight of the core business, business continuity, routine process improvement, and effective communication.
- Drive excellence in execution for proactive risk management and trial oversight.
- Serve as a champion to key business partners and, stakeholders and as a conduit between business partners, quality groups, and governance to enable and promote quality, accountability and quality culture.
- Serve as a standing member of the QP&S Leadership Team.
- Provides strategic leadership and coaching to direct reports in the execution of their functions.
- Attract, develop and lead a high performing global team to support BRQC Janssen, BRQC, Janssen Quality 2020 visions.
- A minimum of a Bachelor’s degree is required; an advanced degree in science or business is preferred.
- A minimum of 15years of related work experience in a medium- to large-scale, matrix-ed Life Sciences organization is required.
- Knowledge of worldwide clinical and preclinical safety compliance regulations and guidelines is preferred.
- Exposure to an array of regulatory and legal requirements within the life science industry is strongly preferred.
- People management skills are required.
- Strong leadership experience collaborating with senior leaders is required.
- Strong influencing skills with ability to influence a broad array of global stakeholders.
- Demonstrated capability making strategic use of quality/compliance data to monitor and raise performance.
- Exceptional written and verbal communications skills.
- Proficiency with Microsoft Office products (Word, Excel, PowerPoint, Outlook and Visio) is preferred.
- This position may require up to 25% domestic and international travel with some occasional overnights and weekends.
Requisition ID: 00001CBU