QA Product Lead

ten23 health; Oberwallis; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Career development

Flexible working arrangements

Learn from highly qualified colleagues

Training options

Pension plan

Annual bonus

Zusammenfassung

ten23 health in Visp, Switzerland is seeking two QA Product Leads to drive excellence across project lifecycles. You will act as the go-to technical QA representative for customers and internal teams, ensuring GMP and regulatory compliance while overseeing QA activities.

You will review quality records, support method transfer, qualification, validation, batch records, and participate in audits. Fluency in German and English is required; independence and cross-functional collaboration are

Qualifikationen

• Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacy, or related field.
• Minimum 8 years hands-on experience in a technical QA role.
• Experience in Drug Product manufacturing and aseptic operations is ideal.
• Strong GMP understanding and experience in sterile pharmaceutical production is a plus.
• Excellent teamwork and communication skills; proactive, future-focused mindset.

Aufgaben

• Act as the primary technical QA representative and customer-facing contact.
• Provide QA oversight across all phases of customer projects with GMP/regulatory compliance.
• Review product quality records (DEV, CAPA, CR) for accuracy and compliance.
• Execute Quality Agreement activities with customers.
• Support method transfer, qualification, verification, and validation activities.
• Review and approve batch records and related documentation.
• Serve as a technical SME during customer audits and health authority inspections.
• Contribute to regulatory submissions with Regulatory Experts.
• Coordinate batch manufacturing and QC release for project activities.
• Generate and approve technical documentation (SOPs, Master Batch Records, specs, sampling plans, defect libraries).

Kenntnisse

Technical QA

GMP knowledge

Communication skills

German language

English language

Independent work

Cross-functional collaboration

Ausbildung

Bachelor’s or Master’s degree in Biochemistry/Biotech/Pharmacy

Jobbeschreibung

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow's medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.

Join our Quality Leadership Team in Visp, Switzerland! We are looking for two QA Product Leads to join us in 2027 and drive excellence across our project lifecycles. If you are a technical QA specialist who enjoys being the "go-to" person for customers and internal teams alike, this is your next move.

Responsibilities

• Act as the primary technical QA representative and point of contact in customer projects, addressing all quality-related technical inquiries and providing expert technical input.
• Provide comprehensive technical QA oversight and support throughout all phases of customer projects, ensuring adherence to relevant GMP and regulatory technical requirements.
• Contribute to, review, and critically assess product-related quality records (DEV, CAPA, CR) for technical accuracy, completeness, and compliance.
• Execute Quality Agreement activities with the customers.
• Provide technical expertise and support method transfer, as well as specific qualification, verification and validation activities in collaboration with other QA disciplines to ensure technical robustness and regulatory compliance.
• Issue batch records (including labels) and provide in-depth technical support for batch record review for any product-related batch documentation.
• Serve as a technical SME during customer audits and health authority inspections.
• Provide technical input and support for regulatory submissions related to customer projects, working closely with Regulatory Experts.
• Own and coordinate the timely and successful batch manufacturing and QC release of all activities related to the product-/customer project.
• Generate review, and approve a wide range of critical customer project-related technical documentation, including product-specific SOPs, Master Batch Records, specifications, sampling plans, and defect libraries, etc. ensuring technical accuracy and GMP compliance.

Qualifications

• Bachelor's or Master's degree in Biochemistry, Biotechnology, Pharmacy, or a closely related technical field.
• Minimum 8 years of hands-on experience in a relevant technical QA role.
• Experience in Drug Product manufacturing, aseptic operations is ideal.
• Strong understanding of and proven ability to thrive within a GMP environment, with experience in sterile pharmaceutical production being a significant advantage.
• Excellent technical teamwork and communication skills, with a proactive approach to contributing ideas and a genuine enthusiasm for shaping the future of our QA function (technical experience in microbiology and QC is a plus!).
• Fluency in both spoken and written German and English to facilitate effective technical communication.
• Ability to work independently and efficiently on technical tasks, while also recognizing and valuing the importance of seamless cross-functional technical collaboration.

Benefits

• A valuable and impactful career development opportunity in an inspiring environment
• Flexible working arrangements and environment with an open culture and diverse workforce
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

For more information and clarification, please connect with Amrith ([e-mail]) from our Talent team!