M&S-Quality Control Lead IFB-Beijing

Job title: Quality Control Lead IFB

• Location: Beijing Site

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Engineering Project Leader within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities

Please indicate here the main job responsibilities

The Quality Control Head 3t Insulin Facility provides leadership for Quality Control during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.

Endorsed quality control decisions at project level, participate in the development of the project and future sites strategy:

Ensures the quality control of the Sanofi-products in a complex environment and within the strongly regulated area of the production of active substances with the chosen quality strategy, the applied processes and technologies as well as the appointed personnel. Assurance of a sustainable compliance of the project with legal and quality requirements by continuous consideration of further and new developments in regulatory requirements. Assurance of the most effective use of the available resources for quality control.

He will be the end user of the new greenfield QC facilities responsible for developing the requirements and specifications with MSAT, defining layout and organization, developing and procuring the required lab equipment per defined list, and defining operating models and capacities of the lab, including added future capacities.

Management:

• Is responsible of the delivery of all the 3t quality control aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality.

• Supports the 3t quality control project team consisting of internal and external experts.

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

• Ensures regular reporting to the Global Project Quality Control Head IFF.

• Ensures strategic workforce planning of the QC organization during both project and routine manufacturing modes.

• Develops strategic and operational synergies with the existing Beijing DP site.

• Works with existing Frankfurt organization and global SME network.

Commissioning & Qualification and Validation:

• Ensures development/transfer, implementation and assurance of Quality Control Head 3t Insulin Facility.

• Ensures execution of project C&Q&V strategy, C&Q&V plans and System impact assessment.

• Ensures the preparation and the execution of DQ, SAT, FAT, IQ, OQ and nP-PQ protocoles and final CQ reports and VMP.

• Interacts with the 6 ton facility to keep benchmark and best practices cross-fertilization.

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

• Ensures test transfers and methods to be ready to support the start up of the greenfield production utilities, facilities and process.

Project Control, Cost & Schedule:

• Overseas the 3t quality control budget and schedule.

• Ensures the regular collection of actual 3t quality control project cost and progress.

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

About you

List here ideally the must-haves criteria to be successful on the role.

Experience

• 5+ years industry experience, preferably within the biopharma and/or Quality Control at an industrial (Pharma or food is preferred) site.
• Minimum of +3yrs in Leadership positions with a proven track record of delivery and compliance.
• Knowledge & experience in Quality Control, 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 including Annex 1 knowledge in production and development of active substances and drug product (e.g. Steriles, Vaccines and Biotechnology).
• Know-how in Quality Control, 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 Chemistry/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.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!