EU QA Operations Manager - cGMP Compliance

Acadia Job Listings; Zug; Hybrid; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Competitive base + bonus + equity

Medical, dental, vision insurance

401(k) with company match

15+ vacation days

Paid holidays

Tuition assistance

Job summary

Acadia Pharmaceuticals seeks a Sr. Manager, Quality Assurance Operations to oversee European cGMP operations, review batch records, and assure quality release of API and drug products.

You'll collaborate with CMOs and internal QA teams to maintain Swissmedic/EMA/MHRA compliance and drive continuous improvement. The role requires a Pharm D or master’s/bachelor’s in life sciences, 5+ years in pharma/biopharma, and solid experience with QMS, CAPA, and audits.

Qualifications

• Knowledge of QA activities and international GMP regulations (ICH, Swissmedic/EMA/MHRA) as they relate to trials, development, and transfer.
• Experience implementing and managing quality management systems (QMS).
• Experience conducting internal and supplier audits and inspections of manufacturing facilities.
• Ability to interpret and apply Quality standards, and communicate across teams.
• Willingness to travel 25–40% and operate in a global context.

Responsibilities

• Oversee CMO quality documentation review and approval.
• Manage batch disposition for API, Drug Product, and materials.
• Support CAPA, deviations, and change management within global GMP framework.
• Ensure conformance to Swissmedic/EMA/MHRA and other international regulations.
• Participate in GMP supplier audits and QA documentation control.
• Lead QA activities in continuous improvement of the Acadia quality system.

Skills

Quality Assurance

GMP Knowledge

Auditing

CAPA

Regulatory Interpretation

Leadership

Communication

Education

Pharm D

Master's or Bachelor’s in Chemistry/Biology/Pharmacy

Tools

Quality Management System (QMS)

GMP Auditing Tools

Job description

Acadia Pharmaceuticals seeks a Sr. Manager, Quality Assurance Operations to oversee European cGMP operations, review batch records, and assure quality release of API and drug products.

You'll collaborate with CMOs and internal QA teams to maintain Swissmedic/EMA/MHRA compliance and drive continuous improvement. The role requires a Pharm D or master’s/bachelor’s in life sciences, 5+ years in pharma/biopharma, and solid experience with QMS, CAPA, and audits.