Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) (60-100%)

Ophtapharm AG seeks a Senior Responsible Person (RP/FvP) in Hettlingen to oversee technical operations, ensure GMP compliance, and serve as the primary liaison with Swissmedic for sterile pharmaceutical manufacturing.

This position holds direct accountability for the technical supervision of operations, ensuring that all medicines meet strict standards for safety, efficacy, and quality. The role provides leadership and oversight of Quality Compliance matters across the commercial entity, supporting the broader quality system while acting as an independent authority that balances regulatory obligations with business needs.

Responsibilities

• Serve as the designated Responsible Person (RP) or Fachtechnisch verantwortliche Person (FvP) in full compliance with Swiss regulatory frameworks, including HMG, AMBV, and Swissmedic Technical Interpretation I-SMI.TI.17.
• Guarantee adherence to Good Manufacturing Practice (GMP) standards and all relevant regulatory commitments throughout manufacturing operations.
• Evaluate quality-critical issues and contribute to decision-making processes that impact product quality, regulatory compliance, and patient safety.
• Act as the main point of contact for Swissmedic, representing the company during inspections and regulatory audits.
• Provide independent quality oversight, ensuring that compliance and quality standards are maintained while supporting operational goals.

Requirements

• Hold an MSc or PhD in Pharmacy, Chemistry, Biology, or a closely related scientific field.
• Meet the professional qualifications and experience criteria required for Swissmedic recognition as a Responsible Person (RP) or FvP under Swiss law.
• Possess at least 5 to 7 years of experience in sterile pharmaceutical manufacturing within a GMP-regulated environment.
• Demonstrate strong expertise in GMP and regulatory requirements, with sound judgment in quality-critical matters and a deep understanding of manufacturing processes and customer needs.
• Be fluent in both English and German, with excellent written and spoken communication skills.

What the company offers

• An attractive pension scheme.
• Free parking on-site.
• Convenient access via public transport.

About the company

Ophtapharm AG is currently undergoing a period of transformation, providing the successful candidate with the opportunity to actively shape the future of its quality organization. The company culture emphasizes short decision-making paths and pragmatic solutions, fostering an environment where quality and business objectives can be effectively aligned.

• Opportunity to actively shape the future quality organization during a period of transformation.
• Environment characterized by short decision-making paths and pragmatic solutions.