Senior Director, Clinical Quality Audit Strategy

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

Position Summary

The Senior Director of Clinical Quality Audit strategy is responsible for defining the development and implementation of audit strategy for all clinical processes, vendors and therapeutic areas. The position provides leadership for the identification and resolution of critical quality risks and issues that may affect BMS. The Senior Director, Clinical Quality Audit strategy is also responsible for effectively engaging with Strategic Sourcing, Procurement and other key stakeholders in BMS. The Senior Director will partner with internal and external vendors to promote a culture of quality, risk management and compliance excellence. The Senior Director will also play a crucial role in assessing, managing and integrating quality throughout mergers, acquisitions and integrations.

Key Responsibilities

• Define and lead the strategic vision for Clinical Processes and Clinical Vendor Oversight, aligning it with organization goals and regulatory expectations to support high quality clinical trial execution.
• Oversee vendor quality oversight activities and manage external quality (e.g., quality agreements with vendors).
• Oversee GCP process quality oversight activities.
• Oversee the incorporation of new technology and innovation in clinical trials ensuring reliability of trial results.
• Design and implement the Clinical Audit Strategy for various Therapeutic Areas.
• Partner with Risk, Governance, Operations (RGO) in the development of the Quality Narrative, in particular with contributions for the audit and inspection portion.
• Design and develop a risk-based audit program.
• Oversee due diligence, integration and/or acquisition activities.
• Incorporate global regulatory trends and changes into the organization as applicable.
• Promotes high standards of quality, compliance, and process excellence through oversight of procedure development/enhancement as well as by leading or contributing to strategic initiatives to ensure delivery of business goals.
• Engage with RGO and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement and lead issue resolution.
• Continually evaluate the strategic approach, drive changes in RDQ processes, and modify the RDQ program to meet the changing needs of the organization, regulatory environment and industry best practice
• Ensure rapid communication of quality issues, to business partners and senior management
• Act as the primary quality representative in high level discussions with vendors and other external stakeholders, addressing complex issues and negotiating resolutions.
• Lead the development of quality integration plans for newly acquired entities, coordinating closely with GQ and R&D.
  
  

Qualifications & Experience:

• University Graduate, Advanced life Sciences degree preferred. Equivalent relevant professional experience may be considered.
• Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
• Demonstrated strong knowledge of ICH/GCP, data integrity, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results-delivering on business and program goals
• Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries
• Broad understanding of digitalization including AI, automation, natural language processing
• Communicates a clear and compelling vision and strategy for the business
• Demonstrated experience with budgeting and planning
• Extensive experience in regulatory inspection preparation, management, and related follow-up
• Strong understanding of financial/budgeting and resourcing principles and utilization of this knowledge to make sound business decisions
• 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
  
  

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Responsibilities

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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