Sr. Manager, Quality Assurance

About the role

Acadia Pharmaceuticals is seeking a Sr. Manager, Quality Assurance Operations to lead cGMP oversight for European activities within its global QA department. The role ensures product quality and regulatory compliance for API, drug product, raw materials, and intermediates used in commercial and clinical settings.

Key responsibilities

• Oversee quality aspects of assigned Contract Manufacturing Organizations (CMOs) and approve CMO quality documentation.
• Manage batch disposition for API, drug product, raw materials, and intermediates.
• Participate in design, implementation, and maintenance of Acadia’s GMP quality management system aligned with Swissmedic, EMA, MHRA, and other international regulations.
• Serve as primary liaison with CMO partners, coordinating cGMP production and continuous improvement initiatives.
• Conduct GMP supplier audits, support technology transfer, process validation, and handle batch documentation, registration reviews, and deviations.
• Lead complaint handling, annual product reviews, continuous process verifications (CPV), CAPA activities, and GMP training programs.

Required profile

• Extensive experience in pharmaceutical quality assurance, preferably within a global environment.
• Strong knowledge of cGMP regulations and international regulatory requirements (Swissmedic, EMA, MHRA).
• Proven ability to manage CMO relationships and lead cross‑functional QA teams.
• Excellent analytical, problem‑solving, and communication skills.

Required skills

• cGMP
• GMP compliance
• Batch record review
• CAPA management
• Validation activities
• GMP audits

What we offer

• Opportunity to impact the quality of innovative therapies for underserved neurological and rare disease communities.
• Collaborative, science‑driven environment with global reach.
• Professional development and continuous improvement programs.