Therapeutic Area Quality Lead

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 contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key responsibilities of the Director, Therapeutic Area Quality Lead include: 1) Design and implement end-to-end quality strategy for respective Therapeutic Area 2) Ensure successful Health Authority (HA) engagement ; 3) Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA; 4) Engage in appropriate activities to support product submissions; 5)Establish strong partnership with business stakeholder.

• Design and implement the quality strategy for the Therapeutic Area
  • Independently assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the Quality Assurance Program where necessary
  • Identify and drive continuous quality process improvements as a consequences of audits, assessments, inspections, trends/metrics and root cause analysis
  • Drive implementation of Quality by Design principles
  • Develop, implements and maintain the program quality plan summarizing the quality strategy by summarizing the result of evidence of quality activities
  • Integrate end -to end quality principles and review project milestones with R&ED/GDD
• Establish strong partnership with business stakeholder
  • Seek to understand and evaluate their priorities
  • Actively participate in and make meaningful contributions
  • Deliver independent expert support and propose solutions
  • Lead the presentation of key data (compliance, conformance, issues and risks) to drive decision making
• Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA
• Initiate appropriate activities to support product submissions
• Ensure successful Health Authority engagement
  • Demonstrate implementation of quality strategy to Health Authorities
  • Sharing the quality plan to Health Authorities
  • Prepare for inspections and support inspections
• Participate/provide expertise in in licensing activities as applicable
• Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.

Degree/Certification/Licensure

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training and experience

Experience - Responsibility and minimum number of years

• Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance

Competencies - knowledge, skills, abilities, other

• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Very experienced in nonclinical/clinical research/pharmacovigilance experience
• In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management
• Understanding of BMS's therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)
• Extensive experience in regulatory inspection preparation, management, and related follow-up
• Demonstrated analytical and conceptual capability-including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data
• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution
• Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication
• Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
• Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies
• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies
• Fosters a culture in which people continually work to improve services, and work processes

Software that must be used independently and without assistance (e.g., Microsoft Suite)

Microsoft Suite, Veeva Vault QMS, SharePoint, other systems as assigned/applicable

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.