M&S - Quality Control Expert - IFB

About the job

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China (IFB). For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.

Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!

Position Overview

The Quality Control method transfer expert will work on establishing the Quality Control laboratory at IFB during the planning phase, qualification through to final approval and transition to routine operations. Together with other Q-functions, the incumbent will develop procedures and documents to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications.

As the project proceeds, this role is expected to evolve to functional leadership of a team consisting of internal and/or external analysts and/or technicians to execute the rest of transfer, qualification, validation and test activities to support project hit the milestone in a compliance manner regarding on HSE, cGMP and Sanofi internal and external regulatory standards.

The Quality Control  Expert will report to the Quality Control Lead IFB.

Main responsibilities:

• Provides analytical expertise for projects, troubleshooting and investigations related to analytical methods and laboratory technologies.

• Creates and reviews protocols and reports related to analytical validation/transfer activities and qualification measures.

• Creates, reviews and maintains precise standard operating procedures for analytical methods for IFB and ensures the alignment with the sending unit in Frankfurt.

• Ensures the performance of all tasks (initially especially equipment qualifications, analytical transfers) in accordance with cGMP and HSE requirements as well as associated instructions, procedures and records

•Ensures the documentation of all required raw data, calculations and information to comply with cGMP and data integrity requirements

• Timely informs the LM about quality or HSE-relevant events (deviations, OOX, etc.) to ensure appropriate investigation and impact assessment.

• Ensures proper documentation of deviations, non-conformities and corrective actions

• Ensures GMP-compliant execution and documentation of quality tests and workflows for pharmaceutical products.

Management:

• Is responsible of the delivery the quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality. Ensure the project is performed according to the Sanofi Standard and Good Practices.

• Lead a team consisting of internal and/or external analysts and/or technicians. Provides appropriate training, mentoring, and coaching, review and development to ensure retention of talented people and robust succession planning across key positions.

• Ensures implementing statutory and company-specific occupational safety guidelines to prevent work accidents and occupational diseases within your area of responsibility. This includes regular communication of occupational safety topics and conducting occupational safety training based on risk assessments.

• Standardize operational processes and cost management with a focus on continuous improvement.

• Collaborates closely with the sending unit in Frankfurt, MSAT and global SME network.

About you

Experience

• Degree in Chemistry/Pharmacy/Biochemistry or Equivalent.

• Ideally MSc or PhD level qualification in science.

• Minimum of 5 years of pharmaceutical or biotechnological industry experience, preferably with practical experience in analytical method transfer/verification and/or instrument qualification and validation.

• Minimum of 2 years in project leadership positions with a proven track record of delivery and compliance.

• Preferably with the knowledge & experience in PAT, automation and/or LIMS.

• Experience in scientific and technical writing

• Effective oral and written communication skills, and innovative thinking.

• Familiarity with strategic planning, balanced judgment and risk analysis.

Soft Skills

• Ability to drive and embrace change

• Cross-functional collaboration

• Leadership and assertiveness

• People development

• Negotiation and influencing skills

• Communication skills

• Decision-making

Technical Skills

• Proficient with typical analytical techniques and software.

• In-depth understanding of GMP principles and data integrity requirement.

• GMP and health-regulated requirements

• International and FDA experience

Languages

• Proficient in academic English/German and Mandarin across all four modalities: listening, speaking, reading and writing.