Lead GMP/GDP QA Compliance & Supplier Audits

Idorsia Pharmaceuticals Ltd; Allschwil; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Idorsia Pharmaceuticals Ltd in Allschwil (Basel Area) is seeking a Senior QA Compliance and Auditing Manager to lead GMP/GDP audits and supplier oversight. You will design, implement and maintain Quality Agreements with external partners and drive risk-based compliance across the organization.

The role requires 7+ years in pharmaceutical QA/compliance, deep knowledge of global GxP standards, and strong leadership and communication skills.

Qualifikationen

• Minimum 7 years in pharmaceutical QA, compliance, supplier quality, manufacturing quality or related GxP functions.
• Experience leading supplier qualification programs and GMP/GDP audits as Lead Auditor.
• Strong knowledge of EU GMP, EU GDP, ICH, PIC/S, WHO, FDA and ISO requirements.
• Proven ability to interpret regulations and implement pragmatic, risk-based compliance solutions.
• Experience in developing and managing Quality Agreements and external partner oversight programs.
• Fluent in English; knowledge of another European language is an asset.

Aufgaben

• Lead supplier qualification lifecycle management for GMP/GDP service providers and suppliers.
• Design, negotiate, implement, and maintain Technical Quality Agreements with external partners.
• Plan and conduct GMP/GDP audits of suppliers, contractors, distributors, and service providers.
• Manage CAPAs, deviations, change controls, investigations and documentation.
• Support Health Authority inspections and customer audits and drive continuous quality improvements.

Kenntnisse

Project management

Leadership

Communication

English fluency

Analytical

GxP knowledge

Quality mindset

Stakeholder influence

Ausbildung

University degree in Pharmacy, Chemistry, Biotechnology, or Life Sciences

Master's degree preferred

Jobbeschreibung

Idorsia Pharmaceuticals Ltd in Allschwil (Basel Area) is seeking a Senior QA Compliance and Auditing Manager to lead GMP/GDP audits and supplier oversight. You will design, implement and maintain Quality Agreements with external partners and drive risk-based compliance across the organization.

The role requires 7+ years in pharmaceutical QA/compliance, deep knowledge of global GxP standards, and strong leadership and communication skills.