EU Analytical QC Lead

Acadia Pharmaceuticals; Zug; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Competitive base + bonus

Medical, dental, vision insurance

401(k) plan with company match

Employee Stock Purchase Plan

Zusammenfassung

Acadia Pharmaceuticals seeks a Sr. Manager, Quality Control EU to oversee analytical methods and specifications used outside North America. You will manage release testing across DS/DP, review validations, and coordinate CSPs for stability work and data trending.

The role requires 3–5 years in pharma QC/QA, strong GMP knowledge across EU/Japan/US, and excellent cross‑functional collaboration. Travel and flexible hours may be involved.

Qualifikationen

• Bachelor’s degree or higher in a health science field; master’s preferred.
• 3–5+ years in pharma manufacturing focusing on quality control/assurance.
• GMP, EU/JP/FDA regulatory requirements knowledge.
• Experience managing outsourced GMDP activities.
• Strong project and risk management skills.

Aufgaben

• Review and approve analytical test results for DS and DP.
• Author analytical method protocols, validations and ICH sections of reviews.
• Lead transfer protocols and reports between laboratories.
• Author stability protocols and reports.
• Coordinate stability studies and reports with CSPs.
• Support regulatory filings reviews and inspections.
• Report stability data and trends to senior management.
• Direct CSPs to enable stability testing activities.

Kenntnisse

Project management

Attention to detail

Negotiation

Stakeholder management

Problem solving

Written & verbal communication

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Health Science

Master’s degree preferred

Jobbeschreibung

Acadia Pharmaceuticals seeks a Sr. Manager, Quality Control EU to oversee analytical methods and specifications used outside North America. You will manage release testing across DS/DP, review validations, and coordinate CSPs for stability work and data trending.

The role requires 3–5 years in pharma QC/QA, strong GMP knowledge across EU/Japan/US, and excellent cross‑functional collaboration. Travel and flexible hours may be involved.