M&S - Quality Control Expert - IFB

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.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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