About the job 

Main responsibilities 

The Quality D&Q Manager IFB (Design & Qualification, Insulin facility Beijing) ensures compliance with FDA, EMA, and Chinese Pharmacopoeia regulations for equipment design and qualification in IFF, Annex 15 and applicable regulations. The Quality D&Q Manager IFB co-develops Design and integrated C&Q strategy with the goal of compliance and state-of-the-art cGMP design and Qualification. Quality D&Q Manager IFB provides expert guidance on cGMP biologics Design and Qualification activities, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), DQ, IQ, OQ and PQ and complex equipment qualification. Provide expert oversight and review of documentation while identifying and mitigating risks. Monitor compliance and support design reviews and qualification of facilities, critical utilities, equipment, and computerized systems to ensure timely execution. 

As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures. 

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval. 

Management: 

• Ensures the project is performed according to the Sanofi Standards and Good Practices. 

• Ensures regular reporting to the Global Quality D&Q Lead. 

Commissioning & Qualification and Validation: 

• Responsible for the project C&Q&V strategy and execution, C&Q&V plans and System impact assessment. 

• Ensures IFF Quality Concepts development and Implementation during Design Review (DR), act as Quality review and support Process Engineering Team (URS, PID, technical documentation) 

• Responsible the preparation and the execution of DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP 

• Interacts with the IFF to keep benchmark and best practices cross-fertilization. 

• Responsible for the consistency of the turnover package to system owners. 

• Responsible for Quality oversight of Supplier Qualification Engineering activities (e.g. FAT, SAT, Vendor documentation and test execution). 

Project Control, Cost & Schedule: 

• Supporting the regular collection of actual quality C&Q project cost and progress. 

• Ensures the project compliance with Sanofi Cost & Schedule Policies and Standard. 

About you 

Experience 

• 3-5 years industry experience, preferably within the biopharma and/or related regulated industry focus on Quality System Management. 

• Knowledge & experience in Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles, transversal validations activities, as well as Pharmaceutical Manufacturing with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking. Familiarity with strategic planning, balanced judgment and risk analysis. 

• Experience working on large capex projects in Asia (China, Singapore, etc) is a strong asset. 

Soft skills 

• Collaborate effectively with peers, stakeholders, partners across the organization to positively impact business results. 

• Act for innovation, initiating new and improved ways of working. 

• Develop teams in anticipation of future business needs. 

• LEAN oriented, problem solving & new way of working. 

• Open minded and curios to learn new tools. 

Technical skills 

• In-depth knowledge of the biologic product license application process, and the associated regulatory requirements. 

• Know-how in Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure, KNEAT solution is a plus. 

Education 

• Degree in Engineering/Science/Pharmacy or equivalent. 

• Ideally MSc or PhD level qualification in Science. 

Languages 

• Excellent communication skills (written and oral) in English 

• Chinese (Mandarin) is a strong asset.