Sr. Manager, Quality Assurance

About the role

The Sr. Manager, Quality Assurance Operations will oversee cGMP European operations within the global Quality Assurance department. This role involves managing quality oversight at Contract Manufacturing Organizations, ensuring compliance with international regulations, and handling batch disposition and quality management systems.

Responsibilities

• Oversee CMOs from a quality perspective and review CMO quality documentation.
• Manage the batch disposition process for API, drug products, raw materials, and intermediates.
• Participate in the design, implementation, and management of the GMP quality management system.
• Ensure compliance with Swissmedic, EMA, MHRA, and other international regulations.
• Serve as a key point of contact with CMO partners for cGMP production and continuous improvement.
• Manage internal investigations, change management, and CAPA plans.
• Provide QA representation on GMP product development teams.

Required skills

• Quality Assurance
• cGMP
• Batch record review
• Quality management systems
• Regulatory compliance
• Supplier audits
• Change management
• CAPA

Nice to have

• Internal audits
• Manufacturing facility inspections
• European language proficiency

Qualifications

• Pharm D, Master's or Bachelor's degree in Chemistry, Biology, Pharmacy or related life science
• Minimum of 5 years related experience within the pharmaceutical or biopharmaceutical industry

About the Company

Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. Their portfolio includes FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome, with a pipeline addressing Alzheimer’s disease psychosis and Lewy body dementia psychosis.