QA Lead

Quality Assurance Specialist

Roche is seeking a dedicated professional to join our team, where we value personal expression and genuine connections to advance healthcare. This role focuses on ensuring product quality, compliance, and operational excellence.

Responsibilities

• Lead the review and approval of Batch Production and Control Records to ensure cGMP compliance.
• Facilitate product release decisions, including certification and aseptic oversight.
• Manage quality oversight for raw materials, suppliers, and third-party service providers.
• Lead the compilation and analysis of Annual Product Quality Reviews (APQR) and identify adverse trends.
• Investigate product quality issues and implement corrective and preventive actions (CAPA).
• Represent Quality Assurance during internal and external audits and regulatory inspections.
• Support technology transfers, new facility startup readiness, and continuous improvement initiatives.

Requirements

• Degree in pharmaceutical sciences, life sciences, chemistry, or a related discipline.
• Minimum of 7 years of experience in pharmaceutical or biotechnology quality assurance, GMP compliance, or operations.
• Proven experience in aseptic filling and new facility startup projects.
• Strong knowledge of FDA/EU cGMP standards and ICH guidelines.
• Excellent problem-solving, decision-making, and communication skills.
• Fluency in English with the ability to collaborate effectively across functions.