Associate Director of Validation
Associate Director of Validation
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Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. Read more: 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
Required:Bachelors degree in Engineering Life Sciences or a related discipline.
Preferred:Advanced degree or professional certification in validation (e.g. IVT PDA or equivalent)
Minimum 8 years experience in validation within pharmaceutical/radiopharmaceutical manufacturing including large-scale capital project support (>$10M).
Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and compliance.
Direct experience managing validation or multidisciplinary project teams and external contractors.
Skills and Qualifications
Strong knowledge of pharmaceutical validation practices including cGMP and FDA/USP/OSHA regulatory requirements.
Expert understanding of facility utility aseptic processing and fill/finish equipment validation.
Advanced proficiency in authoring and managing validation documentation (master plans risk assessments protocols and reports).
Familiarity with qualification of computerized systems and data integrity best practices.
Solid background in vendor management contract review and cost controls within validation scopes.
Excellent written verbal stakeholder and team leadership communication skills.
Proficient in MS Office Suite validation software/applications and computerized maintenance management systems (CMMS).
Willingness to work in radioactive environments and follow strict safety requirements.
Ability to travel and support validation at multiple domestic or international sites.
Physical Demands
Ability to climb ladders and lift up to 25 lbs.
Frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments.
Work Environment
Moderate noise levels.
Exposure to laboratory pharmaceutical manufacturing and radiopharmaceutical production areas.
#RayzeBio
If you come across a role that intrigues you but doesnt 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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 a supportive culture promoting global participation 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 an 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 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Full-Time
