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

Bio-Strath AG is a renowned company that has been manufacturing natural dietary 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 via specialist retail and online.

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

What awaits you:

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

What you bring with you:

• 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 operation, including in technical or leadership responsibility.
• You have sound knowledge of GMP requirements (PIC/S) as well as CH/EU medicinal, food, and feed legislation.
• 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 and at the same time appear confident towards authorities, suppliers, and customers.
• You have a pronounced hands-on mentality as well as very good German and English skills in spoken and written form; other languages are an advantage.

What we offer:

• A key function with great creative freedom and direct reporting to the management
• The chance to independently further develop our quality system instead of just managing 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 transcripts or certificates.

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