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RayzeBio is an innovative biotechnology company based in San Diego, CA, and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary. Since its inception in late 2020, RayzeBio has been dedicated to improving the survival of cancer patients through targeted radioisotopes. As a standalone entity within BMS, RayzeBio is poised to lead the charge in radiopharmaceuticals, leveraging BMS’s world-class oncology expertise. RayzeBio’s lead asset, RYZ101, is currently in Phase 3 testing for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and advancing in early-stage clinical trials for small cell lung cancer (SCLC) and breast cancer. Additionally, RayzeBio is developing a broad pipeline of early drug candidates into early human clinical trials.
RayzeBio is committed to becoming the global leader in radiopharmaceuticals, and this journey requires a seasoned, visionary leader to direct quality operations and ensure world-class compliance and readiness for regulatory inspections.
Summary
RayzeBio seeks an experienced Executive Director, Head of Quality to lead and strategically oversee the entire Quality function at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN. In this pivotal executive role, you will provide leadership and guidance across Quality Assurance, Quality Systems, Quality Control, and Clinical Quality while ensuring GMP and GCP compliance, operational excellence, and readiness for global regulatory inspections, including the FDA’s Pre-Approval Inspection (PAI). Additionally, you will oversee and drive the design, implementation, and continuous improvement of quality systems, ensuring that the highest standards are maintained as we prepare for the commercialization of radiopharmaceutical products.
As a key RayzeBio Manufacturing and Clinical Leadership Team member, you will collaborate closely with senior executives across RayzeBio and Bristol Myers Squibb, driving the vision and execution of quality initiatives that support the safe, effective, and compliant delivery of life-saving therapies. This role reports to the Chief, Product Development and Operations, and is based in Indianapolis, IN.
Key Responsibilities
Lead Quality Operations:
Oversee the entire Quality function at the Radiopharmaceutical Manufacturing Facility and External GMP partners ensuring strict adherence to GMP regulations, company policies, and global regulatory requirements (FDA, EMA, PMDA, etc.).
Oversee the Quality function responsible for GCP oversight of the Clinical Studies ensuring strict adherence to GCP Regulations, company policies, and global regulatory requirements.
Prepare for Regulatory Inspections: Lead and manage the site’s preparation for critical inspections, including Pre-Approval Inspections (PAIs) by the FDA and other regulatory agencies, ensuring readiness and flawless execution.
Operational Excellence and Continuous Improvement: Drive operational excellence across the Quality organization, optimizing processes for product quality, GMP and GCP compliance, supply chain efficiency, and regulatory adherence.
Develop and Lead Quality Teams: Build and inspire high-performing teams across Quality Assurance, Quality Systems, and Quality Control. Foster talent development, mentorship, and a culture of continuous improvement.
Cross-Functional Leadership: Partner with leaders from Facilities & Engineering, Manufacturing, Clinical Operations, MS&T, and IT to ensure alignment in the preparation for commercial-scale operations and regulatory approvals.
Compliance Strategy: Collaborate with cross-functional teams to continuously improve quality management systems, policies, and procedures. Ensure compliance across all quality functions, including clinical trials and CMC (chemistry, manufacturing, and controls).
Regulatory Inspection Leadership: Lead and manage regulatory agency inspections and compliance audits (FDA, EMA, PMDA). Prepare the organization for inspections and address any findings or gaps with urgency and thoroughness.
Operational KPIs & Metrics: Manage and review the site’s key quality performance indicators (KPIs), addressing unfavorable trends and implementing corrective actions.
Quality Culture & Leadership: Champion a culture of quality, integrity, and compliance across the organization. Ensure that quality is prioritized in every aspect of the business, from R&D and manufacturing through clinical operations and ultimately commercial supply. Drive a patient first and “one-Team” approach in all aspects day-to-day operations.
Strategic Planning & Budgeting: Develop and manage the Quality department’s annual budget, ensuring efficient allocation of resources to meet business objectives.
Corporate Leadership: Represent the Quality function in key corporate initiatives and strategic planning discussions, contributing to the growth and development of the business.
Education and Experience
Education: MS/PhD in a relevant scientific or engineering discipline.
Experience: Minimum 20+ years of experience in leading Quality functions in the pharmaceutical or biotechnology industry, with a proven track record in Quality Assurance and Compliance and the successful management of regulatory inspections.
Leadership Experience: Demonstrated leadership experience in managing and developing large, cross-functional teams, including Quality Assurance and Quality Systems across multiple sites.
Regulatory Expertise: Expertise in global regulatory requirements (US, EU, Japan, etc.) and demonstrated experience leading the preparation for and hosting FDA Pre-Approval Inspections (PAIs), as well as other global regulatory agency inspections.
Manufacturing Experience: Extensive experience with GMP operations in a commercial manufacturing environment, preferably with aseptic manufacturing for intravenous products.
Continuous Improvement: Proven experience in operational excellence, continuous improvement, and leading initiatives to optimize business processes.
Clinical and CMC Knowledge: Familiarity with the clinical development process, clinical trial execution and CMC processes is highly desirable.
Skills and Competencies
Strategic Leadership: Proven ability to develop and lead high-performance teams, make tough decisions, and navigate complex, fast-paced environments.
Regulatory Acumen: Deep understanding of regulatory agencies and inspection processes (FDA, EMA, PMDA) and ability to successfully prepare and lead inspections.
Communication: Exceptional communication skills, both written and verbal, with the ability to influence and lead at the executive level.
Cross-Functional Collaboration: Strong ability to build and maintain relationships across diverse teams, fostering a collaborative and results-driven culture.
Problem-Solving: High levels of analytical thinking, problem-solving, and the ability to drive solutions in a fast-paced environment.
Resilience & Adaptability: Ability to quickly adapt to changing environments, manage ambiguity, and drive results under pressure.
Key Leadership Traits
Visionary leadership with a focus on building a sustainable and scalable Quality function that drives compliance, innovation, and operational excellence.
Strategic thinker who can align the Quality function with the organization’s broader goals and execute complex initiatives that support commercialization.
Passionate advocate for quality compliance and patient safety, with a deep understanding of how quality impacts business outcomes.
Able to foster a positive and high-performance organizational culture focused on collaboration, integrity, and compliance.
Why RayzeBio?
Growth Opportunities: Lead a pivotal function in a fast-growing, cutting-edge company that is poised to revolutionize cancer treatment.
Culture of Innovation: Join a dynamic, entrepreneurial culture with access to the vast resources and expertise of Bristol Myers Squibb.
Mission-Driven: Work at the forefront of oncology innovation, with the opportunity to make a real impact on the lives of cancer patients worldwide.
This is a unique opportunity to lead at the intersection of quality, compliance, and innovation within a rapidly advancing biotechnology company. If you’re a proven leader with a passion for ensuring the highest standards in pharmaceutical manufacturing and regulatory readiness, we encourage you to apply.
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment
The noise level in the work environment is usually moderate.
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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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