Head of Quality and Regulatory Affairs (80-100%)

About the job

Bio-Strath AG is a renowned company that has been producing natural supplements for humans and animals for over 65 years. As an owner-managed company with 25 dedicated employees, we distribute our products in 50 countries through specialist retailers and online.

For the leadership and further development of our quality organisation, we are seeking an experienced individual for our location in Herrliberg (ZH) by arrangement.

What to expect:

• You will lead the quality department – currently a team of two people, including the technically responsible person – and be responsible for the quality management system for a manageable portfolio in three regulatory areas: pharmaceuticals, dietary supplements, and complementary feed.
• You will be responsible for Regulatory Affairs in Switzerland – approvals, registrations, notifications, and life-cycle management of existing dossiers – and support processes abroad that are managed by our local partners.
• You and your team will ensure GMP-compliant manufacturing and documentation and work closely with production.
• You will manage supplier and contract manufacturer management including quality assurance agreements and audits, and accompany authority and certification audits.
• You and your team will handle deviations, OOS results, complaints, change control, and CAPA, and be responsible for periodic product quality review.
• You will ensure compliance with medicinal, food, and feed law requirements from labelling to claims and advise management.

What you bring:

• You have a completed university degree in pharmacy, chemistry, or a related natural science.
• You have at least 5 years of experience in quality assurance in a GMP-regulated company, including specialist or leadership responsibility.
• You have solid knowledge of GMP requirements (PIC/S) as well as medicinal, food, and feed legislation in CH/EU.
• You bring practical experience in Regulatory Affairs, ideally also with registrations outside the EU.
• Your leadership style is cooperative: you give experienced specialists the necessary freedom while confidently representing the company to authorities, suppliers, and customers.
• You have a pronounced hands-on mentality and very good German and English skills, both spoken and written; additional languages are an advantage.

What we offer:

• A key role with great scope for design and direct reporting to management
• The chance to independently further develop our quality system rather than just manage it
• A long-term perspective in a stable, owner-managed company
• Short decision-making paths, a collegial team, and attractive employment conditions

Do you value a good working environment and flat hierarchies?

Yes? Then please send us an email with your CV, without certificates or diplomas.