Responsable assurance qualité

GALSER SA; Neuenburg; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

GALSER SA in Neuchâtel, Switzerland, is seeking an experienced Quality Affairs Manager to lead GDP-compliant distribution quality activities for medicinal products. The role focuses on maintaining and improving the QMS, ensuring GDP compliance, and overseeing storage, distribution and market release.

The ideal candidate has a Master’s in Life Sciences, 8+ years in pharmaceutical QA, and strong audit, CAPA and supplier qualification experience, with Swissmedic inspections familiarity.

Qualifikationen

• Master's degree in Life Sciences, Pharmacy or related field.
• 8+ years in pharmaceutical Quality Assurance with GDP experience.
• Proven QA systems experience: SOPs, deviations, CAPAs, change controls.
• Strong knowledge of GDP and Swiss import/distribution requirements.
• Eligible for Responsible Person under Swiss law and Swissmedic rules.

Aufgaben

• Oversee quality activities for storage, distribution and market release of medicinal products in Switzerland.
• Maintain and continuously improve the QMS; ensure GDP compliance.
• Draft, review and approve SOPs, working instructions and quality docs.
• Manage audits, inspections (Swissmedic) and CAPA follow-ups.
• Coordinate supplier qualification, Quality and Technical Agreements, and outsourced GDP activities.

Kenntnisse

Quality Assurance

GDP knowledge

Audit experience

CAPA management

QMS oversight

Supplier qualification

Regulatory liaison

Swissmedic inspections

Documentation control

Ausbildung

Master's degree in Life Sciences or Pharmacy

Tools

QMS software

Jobbeschreibung

Location: Neuchâtel, Switzerland (On-site)

Employment Type: Full-time

Commencement: October 2026 or at a mutually agreed date

Languages Required: English (C1) and French (C1) or German (C1).

About the Role

We are seeking an experienced Quality Affairs Manager to lead quality activities related to the distribution and commercialisation of medicinal products in Switzerland.

The candidate will take responsibility for the maintenance and continuous improvement of the Quality Management System (QMS), ensure compliance with Good Distribution Practice (GDP) requirements and oversee quality activities related to the storage, distribution and market release of medicinal products.

The position is suited to a highly autonomous and experienced quality professional with strong hands-on knowledge of pharmaceutical GDP, quality systems and the Swiss therapeutic products framework.

Key Responsibilities

• Exercise quality oversight of pharmaceutical distribution activities and ensure compliance with applicable Swiss therapeutic products legislation and GDP requirements.
• Oversee and approve the batch release of medicinal products for distribution in Switzerland.
• Maintain and continuously improve the pharmaceutical QMS and ensure that it remains appropriate for the company's activities and distributed medicinal products.
• Draft, review, approve and maintain SOPs, working instructions, policies and other controlled quality documentation.
• Establish, review and manage Quality and Technical Agreements with manufacturers, logistics providers, suppliers, distributors and other external partners (e.g. 3PL).
• Qualify and monitor suppliers, service providers and other GDP relevant partners.
• Ensure appropriate oversight of outsourced GDP activities, including storage, transportation and distribution performed by logistics providers and other third parties.
• Manage deviations, CAPAs, change controls and quality risk assessments and ensure timely investigation, implementation and follow-up.
• Manage product quality complaints and quality defects and coordinate appropriate investigation and follow-up actions with relevant internal and external stakeholders.
• Oversee processes relating to returns, recalls and other distribution related quality events.
• Ensure appropriate traceability of medicinal products throughout the relevant supply and distribution chain.
• Plan and conduct internal audits and self-inspections and coordinate external audits of suppliers and service providers.
• Lead audit preparation, conduct audit interviews, document findings and ensure appropriate follow-up and CAPA implementation.
• Manage inspection activities and manage the preparation, coordination and follow-up of inspections by Swissmedic and other competent authorities.
• Coordinate responses to inspection and audit, and ensure timely implementation and closure of corrective and preventive actions.
• Ensure appropriate GDP training of employees involved in pharmaceutical quality and distribution activities.
• Monitor developments in Swiss GDP requirements and applicable Swissmedic technical interpretations and assess their impact on the company's activities and Quality Management System.
• Collaborate with Regulatory Affairs, Pharmacovigilance, Commercial and other internal functions on quality matters related to medicinal products.
• Act as a key point of contact for pharmaceutical quality matters with suppliers, logistics providers, partners and competent authorities.

Requirements

• Master's degree in Life Sciences, Pharmacy or another relevant scientific discipline.
• Minimum of 8 years of experience in pharmaceutical Quality Assurance, with substantial hands-on experience in GDP regulated activities.
• Demonstrated experience with pharmaceutical Quality Management Systems, including SOP management, deviations, CAPAs, change controls, quality risk management and document control.
• Strong knowledge of GDP requirements and the quality requirements applicable to the import, wholesale and distribution of medicinal products in Switzerland.
• Appropriate education, professional experience and technical knowledge to fulfil the requirements applicable to a Responsible Person under Swiss law and Swissmedic requirements.
• Experience overseeing pharmaceutical storage, transportation and distribution activities.
• Experience with supplier qualification, Quality and Technical Agreements and oversight of outsourced pharmaceutical activities.
• Proven experience as a quality auditor, with the ability to independently plan, conduct, document and follow up internal and external audits.
• Experience preparing for, coordinating and managing Swissmedic or other health authority inspections.
• Experience managing audit and inspection findings, including root cause analysis, CAPA definition and follow-up.
• Experience with product complaints, quality defects, returns and recalls.
• Ability to independently assess quality and compliance issues and take appropriate decisions within a regulated pharmaceutical environment.
• Proven ability to manage multiple priorities and quality activities independently with minimal supervision.
• Strong analytical, organisational and problem-solving skills.
• Excellent written and verbal communication skills.
• Proactive, rigorous, detail-oriented and solution-driven approach.

A Plus

• Knowledge and experience of GMP requirements.
• Experience with Quality Management Systems supporting clinical trial activities and GCP compliance.
• Experience in the CRO environment.
• Experience in Pharmacovigilance / Drug Safety.