Associate Director of Validation

Role Summary

The Associate Director of Validation leads the validation function to ensure 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.

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.

Qualifications

• Required: Bachelor's 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

• 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.

Education

• Required: Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• Preferred: Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent).

Additional Requirements

• Physical Demands: Ability to climb ladders and lift up to 25 lbs; frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments.
• Other Requirements: Travel to support validation at multiple sites; compliance with safety standards for radioactive materials and hazardous equipment.