EU Analytical QC Lead — Stability & Method Transfer

ACADIA Pharmaceuticals Inc.; Zug; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) plan with company match

Paid time off (vacation) 15+ days

Life and disability insurance

Zusammenfassung

Acadia Pharmaceuticals Inc. seeks a Sr. Manager, Quality Control EU to guide analytical methods and release testing across CSPs outside NA, aligning with EU/JP/FDA GMP guidelines. The role reviews method transfers, validates stability protocols, and coordinates stability studies to support regulatory submissions.

You will lead CSP partnerships, ensure timely data trends, and oversee quality reviews of analytical reports for regulatory submissions and inspections.

Qualifikationen

• Bachelor’s degree in a Health Science discipline is required; Master’s degree preferred.
• 3–5 years of pharmaceutical quality control/quality assurance experience.
• Strong knowledge of EU, JP, and FDA GMP regulations and ICH guidelines.
• Proven experience managing outsourced GMDP activities.

Aufgaben

• Review and approve analytical test results for DS and DP.
• Review and/or author analytical method protocols, validations and annual product quality reviews.
• Coordinate transfers of analytical methods between CSPs and laboratories.
• Author stability protocols and reports; monitor stability programs at CSPs.
• Lead analytical data reviews to support batch release and stability assessments.
• Support regulatory filings and inspections with analytical data.

Kenntnisse

GMP regulations

QA experience

Project management

Stakeholder management

Analytical method validation

GMDP management

Communication skills

Ausbildung

Bachelor’s degree in a Health Science

Master’s degree preferred

Jobbeschreibung

Acadia Pharmaceuticals Inc. seeks a Sr. Manager, Quality Control EU to guide analytical methods and release testing across CSPs outside NA, aligning with EU/JP/FDA GMP guidelines. The role reviews method transfers, validates stability protocols, and coordinates stability studies to support regulatory submissions.

You will lead CSP partnerships, ensure timely data trends, and oversee quality reviews of analytical reports for regulatory submissions and inspections.