Associate Director - Quality Management Systems

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
Serve as Process Lead to support end-to-end Governance Controls business processes across the global organization. • Ensure processes are standardized, remain in a state of control, and are both effective and efficient. • Support process architectures of the integrated Quality Management System (QMS), leading process workstreams designed to monitor and improve processes within the integrated GxP QMS framework. • Engage with the broader process owner, process lead network and local site/function process owners in designing and deploying QMS process improvements. • Drive operational excellence, continuous improvement, and process maturity, ensuring compliance with GxP regulatory requirements, BMS Quality standards, and BMS QMS principles.

Key Responsibilities
Maintain global processes, procedures, and training materials in compliance with Global GxP requirements.
• Drive optimal execution of processes across BMS and external partners.
• Identify and prioritize quality process & system improvements.
• Provide training, support, and coaching as required.
• Define process monitoring methods, including data collection and analysis, metrics, and associated targets.
• Define and lead the development of metrics through standard queries and reports with system functionality.
• Monitor process health, ensuring it is in a state of control, efficient, and effective, and develop action plans to remedy issues when necessary.
• Navigate cross-functional teams through ambiguity towards clear and actionable decisions.
• Support development and execution of operational excellence and continuous improvement projects.
• Identify and track progress against key project milestones, partnering with applicable business and quality teams to ensure overall project success.
• Engage leadership from business case development through program delivery, ensuring organizational alignment on scope, schedule, quality, and benefits.
• Participate/lead regulatory surveillance and benchmarking initiatives to stay abreast of changes in regulations affecting QMS processes.
• Support site and function teams during regulatory inspections or audits.
• Serve on systems project teams and committees to ensure timely accommodation of system issues and opportunities. • Support the global process during audits and inspections.
• Required travel up to 25% to ensure processes are globally designed and deployed in an effective and inclusive manner where extensive iterative process design development, training and sustaining of processes are required

Qualifications & Experience

Minimum of a bachelor's degree in a related field (advanced degree preferred).
• 10+ years of experience in a pharmaceutical/biotechnology/advanced therapeutic modality products (ATMP) environment (e.g., research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).
• Knowledgeable of GxP regulations and expectations for core health agencies; thorough understanding of regulatory requirements in relation to QMS.
• Familiar with electronic quality system tools.
• Strong program and project management experience with a proven track record of managing cross-functional programs and the ability to manage multiple, simultaneous projects.
• Familiarity with developing and executing organizational change, including change management strategy and planning.
• Strong problem-solving and analytical skills with the ability to analyze data, performance metrics, assess risks, identify trends, and develop mitigation strategies and improvement opportunities.
• Influential leadership expertise and experience with senior-level interactions.
• Enterprise mindset to think and act across functions and divisions.
• Ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control.
• Strong strategic thinking capability with a strong project management focus.
• Strong leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk.
• Change agility in anticipating and leading others through change and ambiguity.
• Innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
• Ability to communicate with presence and influence in both formal and informal settings, preparing and presenting persuasive written and verbal materials with employees and management at all levels.
• Ability to set priorities and deliver results without constant feedback/input from the manager.
• Ability to identify, manage, and/or escalate issues and risks to timelines.
• Enable QMS alignment with business strategy and ensure business strategy is executed at the process level as aligned with the global process owner.
• Ensure standardization and prioritization of accountable processes at the global level.
• Enable an enterprise mindset and drive cross-function/cross-site collaboration.

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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
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.

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