QA Responsible Person, GDP

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Serve as the QA Responsible Person (RP) for the local release of medicinal products in the Czech Republic, ensuring adherence to GDP/GMP standards.

• Conduct reviews and certifications of batch documentation for Gilead products, which include solid dosage forms (tablets), sterile oncology products, and CAR-T therapies (patient-specific release).

• Ensure compliance with local regulatory requirements while overseeing quality systems and processes.

• Collaborate with global QA, manufacturing locations, and supply chain teams to guarantee timely and compliant product releases.

• Assist in maintaining quality management activities, including deviations, CAPAs, change controls, and readiness for inspections.

⛳️ Requirements

• Must be a qualified Pharmacist eligible to serve as Responsible Person in the Czech Republic (residency in Czech Republic is required).

• A minimum of 1 year of QA experience within the pharmaceutical sector is necessary.

• Familiarity with GDP regulations and the batch release process is essential.

• Experience in sterile manufacturing, oncology products, or advanced therapies (e.g., CAR-T) is highly advantageous.

• Must possess the ability to work independently in a part-time role (0.3–0.5 FTE) with a strong focus on detail and accountability.

🏝️ Benefits

• Opportunities for both personal and professional development in a fulfilling environment.

• Become part of a team that prioritizes collaboration, quality, and positively impacting patients' lives.

• Our core values of Trust, Quality, Passion, Flexibility, and Sustainability inform our decisions and shape our culture.