Sr. Manager, Quality Assurance

Acadia Pharmaceuticals seeks a Sr. Manager of Quality Assurance to oversee cGMP European operations, ensuring regulatory compliance and managing QA personnel and processes.

This position serves as a key leader within the global Quality Assurance department, reporting directly to the Director of Quality Assurance at Acadia GmbH. The role focuses on the strategic oversight of current Good Manufacturing Practice (cGMP) activities across European operations, ensuring that all quality standards are met while supporting the company's broader therapeutic goals.

Responsibilities

• Provide quality oversight for Contract Manufacturing Organizations (CMOs), including the review and approval of their quality documentation.
• Oversee the batch disposition process for active pharmaceutical ingredients, drug products, raw materials, and intermediates.
• Design, implement, and manage the company’s GMP quality management system.
• Ensure the quality management system complies with regulations from Swissmedic, the EMA, and the MHRA.
• Act as the primary liaison with CMO partners regarding cGMP production and continuous improvement initiatives.
• Conduct GMP supplier audits and manage documentation control systems.
• Supervise QA staff involved in technology transfer, process validation, and batch documentation for CMOs.
• Review and verify adherence to Quality Agreements with GMP contract service providers.
• Lead internal investigations, change management processes, and the establishment of Corrective and Preventive Action (CAPA) plans.
• Drive continuous improvement of quality management systems in alignment with GMP standards.
• Ensure QA representation on GMP product development teams and provide strategic direction.
• Define departmental goals and objectives for review by senior management.

Requirements

• Pharm D, Master’s, or Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related life science field.
• At least five years of progressively responsible experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of QA activities and ICH, Swissmedic, EMA, and MHRA GMP regulations.
• Proven ability to interpret and apply cGMP regulations for Swissmedic, EMA, and MHRA.
• Fluent proficiency in spoken and written English.

Nice to have

• Experience in implementing and managing quality management systems.
• Background in conducting internal and supplier audits, as well as manufacturing facility inspections.
• Proficiency in additional European languages.
• Experience working within a global organization, particularly in the EU or Switzerland.

About the company

Acadia Pharmaceuticals is dedicated to transforming scientific potential into meaningful innovations for communities affected by neurological and rare diseases. The company is focused on developing the next generation of therapeutic advancements through a robust and diverse pipeline.

• Commitment to addressing underserved neurological and rare disease communities.
• Focus on developing next-wave therapeutic advancements.
• Support for a robust and diverse research pipeline.