Associate Director, Quality Operations

Primary Responsibilities

• Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products


• Manage batch review, disposition, and release activities for drug substance and drug product manufacturing and packaging


• Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs


• Serve as the primary quality interface with CMOs to ensure compliance with SOPs, Quality Agreements, and regulatory expectations


• Lead investigations, change control, CAPA activities, and risk assessments related to GMP operations


• Support complaint handling activities, including investigation and closure


• Support the design, implementation, and maintenance of Acadia’s GMP quality management system in compliance with US and international regulations


• Provide on-site GMP quality support at CMOs, including participation in audits and inspections as required


• Represent Quality Assurance on cross‑functional GMP manufacturing, packaging, supply chain, and development teams


• Other duties as assigned

Education/Experience/Skills

• 
  
  Bachelor’s degree in Chemistry, Biology, or a related life science
  
  


• 
  
  Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry
  
  


• 
  
  Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations
  
  


• 
  
  Demonstrated experience with US FDA and international GMP regulations
  
  


• 
  
  Experience overseeing CMOs and outsourced GMP manufacturing activities
  
  


• 
  
  Ability to travel up to 15–20%
  
  

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.