Associate Director, Investigations

Position Summary

• Tackle rare and dynamic challenges
• End-to-end management of deviations, investigations, and CAPAs
• Leading a team with similar responsibilities
• Leading Manufacturing Excellence

Responsibilities

• Ensure consistent, timely, and inspection-ready execution of quality records
• Establish and oversee the strategy, governance, and performance of TechOps quality systems
• Build and enhance partnerships with key stakeholder groups
• Prepare for regulatory inspections and represent Technical Operations during health authority interactions
• Define and govern production systems frameworks
• Drive system-level improvements to enhance process robustness and reduce recurrence of deviations
• Contribute to developing strategy and governance for Manufacturing Excellence

Requirements

• Bachelor’s degree in science, engineering, or related field required
• 10+ years of experience in biopharmaceutical, biotechnology, or gene therapy manufacturing
• 7+ years of management experience
• Deep knowledge of GMP regulations and their application in biologics or gene therapy manufacturing
• Proven experience driving operational excellence, continuous improvement, and large-scale process transformation
• Strong leadership capability with experience building and developing high-performing teams
• Expertise in root cause analysis and structured problem-solving methodologies
• Experience with electronic quality systems (e.g., Veeva Vault) preferred

Physical Demand

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights
• Work in a lab environment requiring special protective clothing

Pay Range

Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range: $191,500—$236,600 USD

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans