Quality Control Project Lead

Die Position

We are seeking a highly motivated and experienced Quality Control Project Lead (QC-PL) to oversee and coordinate GMP analytics in QC IMP for synthetic molecules (PTDC-A QC-IMP). Our department is responsible for testing direct materials, Active Pharmaceutical Ingredients (APIs), and drug products, conducted both internally and externally at Contract Manufacturing Organizations (CMOs). Our team of skilled associates and scientists manages critical analytical tasks, including stability studies, validations, and method transfers.

• Project Management: Lead and oversee analytical projects, ensuring strict adherence to GMP regulations, timelines, and quality standards.

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

• Analytical Oversight: Ensure all testing is conducted according to regulatory guidelines, maintaining the highest standards of data integrity.

• Data Review and Reporting: Review analytical data for precision, accuracy, and completeness.

• Vendor Management: Collaborate with CMOs to ensure efficient communication, project execution, and compliance for all stability studies.

• GMP Compliance: Ensure all stability activities strictly adhere to internal SOPs, GMP standards, and relevant regulatory requirements.

• Problem-Solving: Proactively address and resolve issues related to stability studies, including troubleshooting analytical methods and managing deviations.

• Cross-Functional Collaboration: Partner closely with Quality Assurance, Analytical Development, and Manufacturing teams to drive project success.

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

• Experience: Minimum of 3–5 years of professional experience in a GMP-regulated environment, with a strong focus on stability studies and quality control.

• Technical
  
  Skills:
  
  Proficient in stability testing methodologies, including HPLC, GC, and other key analytical techniques.

• Regulatory Knowledge: In-depth understanding of ICH guidelines, FDA, EMA, and other global regulatory requirements pertinent to stability programs.

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

• Language
  
  Skills:
  
  Business fluent English is a must, German is a plus

• Matrix-Leadership: Previous project management or Lab management experience

• Vendor Relations: Demonstrated experience managing CMO relationships and overseeing external stability studies.

• Technical Tools: Proficiency in statistical analysis software and stability data trending tools.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building teams that represent a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Roche is an equal opportunity employer.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.