Director, Data & Vendor Quality

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.

The Data and Vendor Quality Lead will be mainly responsible for design and implementing the strategy for vendor and data from a quality perspective and delivering the full range of quality related activities in the area or responsibility.

Key responsibilities of the Data and Vendor Quality Lead include:

• Design and implement the quality strategy for Vendor and Data
• Drive implementation of Quality by Design and Data Integrity principles
• 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 consequence of audits, assessments, inspections, Quality Events, trends/metrics and root cause analysis
• Provide input into program quality plan summarizing the result of evidence of quality activities related to vendor oversight and data integrity
• 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/Support process alignment and implementation of changes
• Present key data (compliance, conformance, issues and risks) to drive decision making
• Ensure independent vendor quality oversight
• Provides direction and oversight to the vendor qualification and audit program to ensure regulatory compliance and focus on identified risks
• Leads/ supports the development of clinical Quality Agreements and the set-up of the respective quality governance
• Manages QA-to-QA relationship with preferred/critical CROs and vendors
• Actively monitor and maintains industry-wide expertise of digital health e.g., digital biomarker, virtual clinical trials, data transfer and governance, automation, and artificial intelligence
• Manage for cause, critical and/or complex quality issues as well as serious breaches for the area of responsibility (vendor and/or data related)
• Engage in appropriate activities to support product submissions
• Represents RDQ at Quality Councils (chair/co-chair), oversight committees and Community of Practices
• Supports ongoing inspection readiness in the area of responsibility and implement required activities
• Participate and provides strategic direction for preparation, execution and close out of Health Authorities Inspections in collaboration with Inspection Management

Requirements

• B.S. and/or M.S. in Chemistry, Biology, IT or Health related field
• Minimum 8 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
• Demonstrated strong knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Demonstrated ability to work in an international environment leading global quality functions
• 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
• Broad working knowledge of data integrity, computerized system validation, automation, data analytics
• Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
• Proven experience in regulatory inspection preparation, management, and related follow-up
• Demonstrated analytical and conceptual capability—including capacity to develop/translate long-range strategic plans into short-range operational processes/systems/goals and ability to make sound decisions/recommendations with global perspective
• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution
• Excellent communication skills
• Ability to manage complex assignments/projects and effectively deliver all expected deliverable in a timely manner and proactively communicate changes in pre-established goals and deadlines
• Able to effectively prioritize, multi-task and work under pressure – and promote the same across the team
• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies
• Microsoft Suite, Veeva Vault QMS, SharePoint, Spotfire, other systems as assigned/applicable
• Up to 20% travel to attend professional meetings and seminars.

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.