Quality Control Project Lead

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The 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.

The Opportunity

• 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.
  

Who You Are

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

• Experience: Minimum of 35 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
  

Preferred Qualifications

• 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. Are you ready to apply

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 life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.