Associate Director of Validation

Associate Director of Validation

Bristol Myers Squibb – Rayze Bio (San Diego, CA)

We are looking for an experienced leader to head the validation function for our pharmaceutical and radiopharmaceutical manufacturing operations. The Associate Director of Validation will develop and execute validation strategies, oversee cross‑functional teams, and ensure compliance with cGMP, FDA, USP and other regulatory requirements.

• 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.
• Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development.
• Collaborate closely with site leadership, engineers, QA/Quality, and external vendors 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.
• 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.

• Required:
  
  Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Preferred:
  Advanced degree or professional certification in validation (IVT, PDA or equivalent).
• Minimum 8 years of validation experience within pharmaceutical/radiopharmaceutical manufacturing, including large‑scale capital project support (> $10 M).
• Demonstrated experience with radiopharmaceutical or pharmaceutical validation systems and compliance.
• Direct experience managing validation or multidisciplinary project teams and external contractors.

• Strong knowledge of pharmaceutical validation practices and cGMP, 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, 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 CMMS.
• Willingness to work in radioactive environments and follow strict safety requirements.
• Ability to travel and support validation at multiple domestic or international sites.

• Ability to climb ladders and lift up to 25 lbs.
• Frequent interaction in laboratory or manufacturing settings; PPE required in controlled environments.

• Moderate noise levels.
• Exposure to laboratory, pharmaceutical manufacturing, and radiopharmaceutical production areas.

Indianapolis – Rayze Bio – IN: $164,838 – $199,745 (annual base). Additional incentive cash and stock opportunities may be available. Operating location, responsibilities, and experience are considered in final compensation.

Medical, pharmacy, dental and vision coverage; wellbeing programs; 401(K); disability and life insurance; paid holidays; sick time; parental and caregiver leave; additional perks such as tuition reimbursement and recognition programs.

Bristol Myers Squibb is an equal opportunity employer. We support people with disabilities through a transparent recruitment process and reasonable accommodations. BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws.

We will never request payments, financial information, or social security numbers during our application or recruitment process. Data processed in connection with role applications will be treated in accordance with applicable privacy policies and regulations.