EU Quality Control Lead — Analytical Methods & Release

ACADIA Pharmaceuticals Inc.; Baar; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Competitive base, bonus, new hire andO

Employee Stock Purchase Plan

Zusammenfassung

Acadia Pharmaceuticals Inc. seeks a Sr. Manager, Quality Control EU to direct analytical methods and specifications outside North America, ensuring release testing and stability data are robust across DS/DP labs and CSPs. You will oversee method transfers, validations, and regulatory documentation while coordinating with internal teams and external partners.

The role emphasizes leadership in stability programs, data review, and regulatory submissions with travel to EU CSPs as needed.

Qualifikationen

• Minimum 3–5 years in pharmaceutical manufacturing with focus on quality control/assurance
• Strong knowledge of EU, JP and FDA GMP regulations and ICH guidelines
• Experience managing outsourced GMDP activities
• Excellent organizational and project management skills
• Strong attention to detail and commitment to quality
• Effective negotiation and stakeholder management skills

Aufgaben

• Review and approve analytical test results for DS and DP
• Review/author analytical method protocols, validations and QA sections of APRs
• Review/author analytical transfer protocols and reports between laboratories
• Author stability protocols and reports
• Coordinate stability studies and report results
• Lead analytical data review at CSPs
• Support regulatory filings by reviewing analytical reports
• Assist during inspections by local health authorities
• Direct CSPs to facilitate stability testing and report deviations
• Report stability data/trending to senior management

Kenntnisse

GMP regulations

Project management

Analytical data review

Stakeholder management

Communication skills

Problem-solving

Risk-based decision making

Ausbildung

Bachelor’s degree in Health Science

Master’s degree preferred

Jobbeschreibung

Acadia Pharmaceuticals Inc. seeks a Sr. Manager, Quality Control EU to direct analytical methods and specifications outside North America, ensuring release testing and stability data are robust across DS/DP labs and CSPs. You will oversee method transfers, validations, and regulatory documentation while coordinating with internal teams and external partners.

The role emphasizes leadership in stability programs, data review, and regulatory submissions with travel to EU CSPs as needed.