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The Position

Job Posting Quality Control Project Lead (QCPL) Stability Studies

We advance science so that we all have more time with the people we love.

We are seeking a highly motivated and experienced Quality Control Project Lead (QCPL) to oversee and coordinate GMP stability analytics in Synthetic Molecules Technical Development. The QCPL will be responsible for managing both API (Active Pharmaceutical Ingredient) and drug product stability studies conducted internally as well as externalized studies at Contract Manufacturing Organizations (CMOs).

The Opportunity

• Project Management: Lead and oversee stability study projects to ensure compliance with GMP regulations timelines and quality standards.

• Stability Study Coordination: Coordinate internal and external (CMO) stability studies for synthetic molecules including APIs and drug products.

• Analytical Oversight: Ensure stability testing is conducted according to regulatory guidelines and data integrity is maintained. Data Review and Reporting: Review analytical data for precision accuracy and completeness. Prepare and present stability study reports.

• Vendor Management: Collaborate and maintain strong relationships with CMOs to ensure efficient communication and of stability studies.

• Compliance and Quality Assurance: Ensure all stability activities adhere to internal SOPs GMPs and regulatory requirements.

• ProblemSolving: Address and resolve issues related to stability studies including troubleshooting analytical methods and deviations. CrossFunctional Collaboration: Work closely with Quality Assurance Analytical Development Development and Manufacturing teams.

Who you are

• Education: Bachelors or Masters degree in Chemistry Pharmaceutics or a related field.

• Experience: Minimum of 35 years of experience in a GMPregulated environment with a focus on stability studies and quality control.

• Technical Skills: Strong knowledge of stability testing methodologies HPLC GC and other analytical techniques.

• Regulatory Knowledge: Indepth understanding of ICH guidelines FDA EMA and other global regulatory requirements related to stability studies.

• Project Management: Demonstrated ability to manage multiple projects simultaneously with a high degree of organization and efficiency.

Preferred Qualifications:

• Certifications: PMP (Project Management Professional) or equivalent certification is a plus.

• Experience: Experience working with CMOs and managing external stability studies.

• Skills: Knowledge of statistical analysis software and stability data trending tools.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10700 employees from over 100 countries come together at our Basel/Kaiseraugst site which is one of Roches largest sites. Read more.

Besides extensive development and training opportunities we offer flexible working options 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as childcare facilities medical services restaurants and cafeterias as well as various employee events.