Executive Director Clinical Development & Quality Operations
Location: Princeton, NJ, United States
Posted on: Jul 13, 2020
Profile:
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contributes to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Executive Director, Clinical Development & Quality Operations is a critical management position within the R&D Quality organization that is responsible for the development and strategic oversight of the Therapeutic Area Quality, Vendor and Data Quality as well as Quality Risk Management.
Key Responsibilities:
- Oversee the quality strategy across Therapeutic Areas.
- Define and implement the quality strategy for vendor selection, management, and oversight.
- Drive Quality Risk Management and Data Quality activities in Clinical Development.
- Build and lead a Global Quality Strategy organization that provides experienced Quality Assurance support for Clinical Development projects and processes.
- Ensure development and implementation of a quality strategy to cover data quality and vendor quality.
- Oversee vendor quality oversight activities and manage external quality (e.g., quality agreements with CROs, setup of quality councils).
- Oversee the incorporation of new technology and innovation in clinical trial quality.
- Drive the continuous improvement of Data Quality and Data Integrity within R&D.
- Promote Quality by Design for non-clinical and clinical protocols.
- Ensure submission and inspection readiness.
- Drive the R&D Quality Risk Management System.
- Promote high standards of quality, compliance, and process excellence.
- Engage with executive management and cross-functional business partners to identify areas of compliance risk.
- Ensure rapid communication of quality issues to Health Authorities and senior management.
Qualifications:
- B.S. and/or M.S. in Chemistry, Biology, or Health-related field.
- Minimum of 12-15 years of progressive responsibility in biopharmaceutical, GCP-related quality environment.
- At least 5 years of people management experience.
- Proven track record of building and maintaining high-performance teams.
- Exemplary leadership and influence management skills.
- Demonstrated strong knowledge of ICH/GCP and regulatory guidelines.
- In-depth knowledge of applied risk management.
- Expert understanding of the overall audit process.
- Extensive experience in regulatory inspection preparation.
- Strong understanding of financial/budgeting principles.
- Demonstrated analytical and conceptual capability.
- Proven problem-solving skills.
- Excellent communication skills.
- Project Management skills.
- Organizational/Time Management skills.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Company: Bristol-Myers Squibb
Req Number: R1527014_EN
Updated: 2020-07-13
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
#J-18808-Ljbffr
