Associate Director of Validation

Associate Director Of Validation

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. 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.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Associate Director Of Validation is responsible for leading the validation function to ensure that manufacturing facilities, utilities, equipment, processes, and computerized systems comply with regulatory and company standards for pharmaceutical / radiopharmaceutical production. This role oversees validation activities from initial planning through execution, manages a cross-functional team, and ensures alignment with regulatory requirements (cGMP, FDA, USP, and other relevant bodies). The ideal candidate has extensive experience in validation within radiopharmaceutical or pharmaceutical manufacturing and a strong technical background in process and facility qualification.

Key Responsibilities

• Lead, plan, and execute the validation strategy for manufacturing facilities, utilities, equipment, process technologies, and computerized systems.
• Develop and oversee validation master plans, protocols (IQ / OQ / PQ), and reports for new or expanded manufacturing capabilities (facility, equipment, utilities, and processes).
• Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development of validation personnel.
• Collaborate closely with site leadership, engineers, QA / Quality, and external vendors and contractors to ensure timely and compliant validation delivery for expansion, renovation, and site build projects.
• Ensure adherence to budget, schedule, and quality standards within validation scope across all site projects.
• Review and approve technical documentation, validation protocols, risk assessments, and qualification deliverables.
• Manage and resolve deviations, CAPAs, and change controls related to validation and qualification activities.
• Support regulatory inspections, audits, and responses by ensuring site validation compliance and documentation integrity.
• Lead validation efforts to support site / facility strategic initiatives, new technology integration, and global harmonization as needed.
• Drive continuous improvement of validation processes for enhanced site reliability and regulatory compliance.
• Lead and mentor the deviation investigations team for the site.
• Uphold all safety standards; ensure safe handling of radioactive materials and hazardous equipment throughout validation activities.

Education and Experience

$10M).

Skills and Qualifications

Physical Demands

Work Environment