Quality Control Project Lead

Roche seeks a Quality Control Project Lead in Basel to coordinate GMP analytics for synthetic molecules, APIs, and drug products, ensuring regulatory compliance and data integrity.

This position focuses on managing and directing analytical activities within the Quality Control department, specifically for synthetic molecules. The role ensures that testing of direct materials, Active Pharmaceutical Ingredients (APIs), and final drug products meets strict quality and regulatory standards.

Responsibilities

• Direct analytical projects to guarantee compliance with GMP rules, deadlines, and quality benchmarks.
• Manage internal and external stability testing for synthetic compounds, APIs, and finished products, including coordination with Contract Manufacturing Organizations (CMOs).
• Verify that all testing procedures follow regulatory guidelines and uphold rigorous data integrity standards.
• Evaluate analytical results for accuracy, precision, and completeness.
• Work with CMOs to facilitate clear communication, smooth project execution, and adherence to compliance requirements for stability studies.
• Ensure all stability-related activities comply with internal Standard Operating Procedures (SOPs), GMP standards, and applicable regulations.
• Identify and resolve issues arising from stability studies, such as troubleshooting analytical methods and handling deviations.
• Collaborate with Quality Assurance, Analytical Development, and Manufacturing teams to achieve project goals.

Requirements

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutics, or a related discipline.
• 3–5 years of experience in a GMP-regulated setting, with a strong emphasis on stability studies and quality control.
• Strong proficiency in stability testing methods, including HPLC, GC, and other essential analytical techniques.
• Comprehensive knowledge of ICH guidelines, FDA, EMA, and other global regulatory requirements relevant to stability programs.
• Proven ability to manage multiple projects simultaneously with high organization, efficiency, and attention to detail.
• Business fluent English language skills are required.

Nice to have

• Knowledge of the German language is advantageous.
• Prior experience in project management or laboratory management.
• Experience managing CMO relationships and overseeing external stability studies.
• Proficiency with statistical analysis software and stability data trending tools.

About the company

Roche employs over 100,000 people worldwide dedicated to advancing science. The company’s mission is to prevent, stop, and cure diseases while ensuring access to healthcare for current and future generations. The culture fosters personal expression, open dialogue, and genuine connections, valuing employees for who they are and empowering them to explore new possibilities and deliver life-changing healthcare solutions.

• The environment encourages personal expression, open dialogue, and genuine connections.
• Employees are valued, accepted, and respected for who they are.
• The mission focuses on preventing, stopping, and curing diseases and ensuring healthcare access.
• The company empowers staff to explore new possibilities, foster creativity, and keep ambitions high.