Head of Quality Assurance (m/w/d)

Accord Healthcare; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Accord Healthcare AG Switzerland seeks an experienced Associate Director, Head of Quality Assurance & FvP to lead the quality function, ensure GMP/GDP compliance, and maintain Swissmedic regulatory accountability for licensed activities.

The role combines strategic leadership with hands-on quality management, overseeing QMS, batch release, and regulatory interactions while driving a culture of quality across the Swiss affiliate.

Qualifikationen

• 8–10+ years of Quality Assurance experience in pharma.
• Swissmedic-approved FvP or eligible to act as FvP.
• Fluent in German and English; French is an advantage.

Aufgaben

• Lead the local Quality team and foster a strong quality culture.
• Serve as Swissmedic-approved FvP and regulatory quality representative.
• Ensure compliance with Swiss regs, GMP/GDP, and company quality standards.
• Oversee QMS and drive continuous improvement initiatives.
• Approve batches for release in Switzerland.
• Lead investigations, CAPA, risk management, and inspections readiness.
• Manage regulatory inspections and interactions with Swissmedic.

Kenntnisse

Leadership

Stakeholder management

Communication skills

German language

English language

Ausbildung

University degree in Pharmacy / Life Sciences / Chemistry

Jobbeschreibung

The Associate Director, Head of Quality Assurance & Fachtechnisch verantwortliche Person (FvP), is responsible for leading the Quality function of Accord Healthcare AG Switzerland and ensuring full compliance with Swiss pharmaceutical regulations, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), narcotics legislation, and all applicable Swissmedic requirements.

The role serves as the Swissmedic-approved Fachtechnisch verantwortliche Person (FvP) and therefore carries personal regulatory accountability for ensuring that all licensed activities are conducted in compliance with applicable Swiss legislation and regulatory requirements. In accordance with Swiss law, the FvP exercises independent professional judgement in all quality-related matters, including product release decisions and the management of quality and compliance risks. These responsibilities are executed independently from business management and commercial considerations.

As Head of Quality Assurance, the position combines strategic leadership, operational excellence, regulatory accountability, and people management. The incumbent acts as the primary quality representative towards Swissmedic, Corporate Quality, global stakeholders, and external business partners while fostering a strong culture of quality and compliance across the Swiss affiliate.

Why Join Accord

At Accord, we combine the strength of a global healthcare company with the agility of an entrepreneurial organization.

As our Head of Quality Assurance & FvP Switzerland, you will play a key role in ensuring the highest standards of quality, compliance, and patient safety. You will lead quality initiatives across the Swiss affiliate, partner with senior stakeholders, and help shape a strong quality culture while supporting business growth in a highly regulated environment.

We believe that sustainable success is built on quality, integrity, and continuous improvement. That's why we empower our leaders to take ownership, drive meaningful change, and make a lasting impact on patients, customers, and the organization.

What You'll Be Doing

• Lead, coach, and develop the local Quality team while fostering a strong quality and compliance culture.
• Serve as the Swissmedic-approved FvP and act as the key quality representative for regulatory authorities.
• Ensure compliance with Swiss pharmaceutical regulations, GMP/GDP requirements, and company quality standards.
• Oversee the Quality Management System (QMS) and drive continuous improvement initiatives.
• Approve pharmaceutical product batches for release to the Swiss market.
• Lead quality investigations, CAPA activities, risk management processes, and inspection readiness programs.
• Manage regulatory inspections, audits, and interactions with Swissmedic and other health authorities.
• Oversee supplier qualification, quality agreements, and third-party quality activities.
• Ensure compliant management of product complaints, recalls, distribution activities, and quality metrics.
• Partner closely with Regulatory Affairs, Supply Chain, Pharmacovigilance, Commercial, and Global Quality teams to support business objectives while maintaining the highest quality standards.

The Person

• University degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline.
• Swissmedic-approved FvP or eligibility to act as FvP.
• 8 - 10+ years of Quality Assurance experience within the pharmaceutical industry, including significant experience in Switzerland.
• Strong knowledge of Swiss pharmaceutical regulations, GMP/GDP requirements, and quality management systems.
• Proven experience with batch release, audits, inspections, and regulatory authority interactions.
• Experience in supplier qualification, quality investigations, CAPA management, and quality risk management.
• Previous leadership experience with strong stakeholder management and communication skills.
• Fluent in German and English; French is an advantage.
• Experience in multinational pharmaceutical environments is a plus.
• Willingness to travel occasionally and work on-site in Switzerland as required.

Ready to Make a Difference?