Quality Control Project Lead (QC-PL) - Stability Studies

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Job Posting - Quality Control Project Lead (QC-PL) - 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 (QC-PL) to oversee and coordinate GMP stability analytics in Synthetic Molecules Technical Development. The QC-PL 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 execution of stability studies.

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

• Problem-Solving: Address and resolve issues related to stability studies, including troubleshooting analytical methods and deviations. Cross-Functional Collaboration: Work closely with Quality Assurance, Analytical Development, Development, and Manufacturing teams.

Who you are

• Education: Bachelor's or Master's degree in Chemistry, Pharmaceutics, or a related field.

• Experience: Minimum of 3-5 years of experience in a GMP-regulated 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: In-depth 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

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s 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 child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.