Job title: Quality Manager MES (IFB)
Job type: Permanent, Full time
About the job
Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. 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 Manager MES-IFB is responsible for ensuring that all aspects of Quality Assurance activities for the project on the Manufacturing Executions System are executed on time and in accordance with the project, local and global requirements, and applicable regulations.
As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of qualification/validation strategies, implementation of QMS measures in IFB 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.
Main responsibilities:
Quality Management & Compliance
Ensure quality culture, quality mindset and quality GMP compliance performance and continuous improvement engaging all functions and organizational levels across the project and future sites to ensure that the requirements of GMPs are met
Deliver Quality activities in accordance with IFB planning & project needs, including writing, reviewing and releasing documentation as required.
Responsible Quality Subject Matter Expert (SME) for the project on all matters related to Quality assurance, developing MES IFB and assuring quality compliance in project execution.
Participating in IFB electronic batch record design and development, responsible for electronic batch review approach development and ensure Sanofi global procedures and local regulations are met.
Actively engage in Smart factory initiatives and ensure local implementation meets related global standards and local regulations.
Deliver Quality activities in accordance with IFB planning & project needs, including writing, reviewing, and releasing documentation as required.
Develop, update, and promote Sanofi Global Quality Documentation, GOPs or Global procedures.
Communication & Reporting:
Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Assurance deliverables.
Ensure that the project is executed in accordance with Sanofi standards and Good Practices.
Report on key project deliverables related to Quality Assurance, ensuring timely and effective communication and escalation of quality issues to the appropriate levels of management.
Contribute to the Digital strategy and transformation through appropriate communication within the project.
Provides regular reporting to the IFB Quality Lead and Global Quality Lead
Project Execution & Validation:
Support execution of project C&Q&V strategy, CSV strategy, alarm strategy etc. related to data integrity.
Support the preparation and execution of testing protocols, reports, and VMP.
Support the review/approval of validation protocols and final reports.
Collaborate with the facilities in Sanofi to maintain benchmark standards and share best practices.
Project Control, Costs & Schedule:
About you
Experience
Degree in Science/Pharmacy/Computer science or Equivalent.
Ideally MSc level qualification.
3-5 years industry experience, preferably within the biopharma and/or related regulated industry.
In-depth knowledge of API manufacturing process, and related requirement in pharmaceutical industry.
Experience: Practical experience in MES implementation in pharmaceutical industry, experience in Smart factory implementation, and is familiar with related digital systems such as LIMS, SAP etc.
Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation, batch review and release process, familiar with industry guidance and best practices
Experience in scientific and technical writing
Effective oral and written communication skills, and innovative thinking.
Soft Skills:
Driving change
Cross-functional collaboration
Decision-making
People development
Negotiation and influencing skills
Business partnering
Communication skills
Leadership and assertiveness
Technical Skills:
Project Management
Data integrity
Quality Management systems
Continuous improvement management
GxP and health-regulated requirements, including FDA,EU,China regulation requirements.
Languages:
Chinese(fluent, both written and spoken)
English (fluent, both written and spoken)
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.
Pursue Progress. 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!
