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Full-time
bachelor degree, postgraduate degree
Healthcare, Prevention and Wellness Programs, Gender-neutral Parental Leave
Posted 34d ago
Apply by Nov 8
~40 hrs/week
Responsibilities
Responsible for the timely execution of quality assurance for a new insulin drug substance facility in Beijing, ensuring compliance with local and global regulations. This includes managing C&Q&V strategies, implementing quality risk measures, and providing quality oversight throughout the project phases.
Requirements
Requires a degree in Science or Pharmacy (MSc preferred) with 3-5 years of industry experience in biopharma or regulated industries. Candidates must have practical experience in quality operations, risk management, and knowledge of biologic product license applications.
Full job description
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 Assurance Manager-IFB is responsible for the timely execution of all aspects of quality assurance for the project, in compliance with project-specific, local, and global requirements as well as applicable regulations.
As an integral member of the project quality team, this role carries overall responsibility for participating in project workstreams, ensuring the proper implementation of qualification/validation strategies, implementing quality risk measures within the IFB project, and providing support and guidance for quality risk processes and procedures.
This role is expected to work independently, with a high degree of autonomy and decision-making authority, to ensure ongoing adherence to approved documents and current Good Manufacturing Practices throughout all project phases.
Main responsibilities:
Management:
Ensure that the project is executed in accordance with Sanofi standards and Good Practices.
Provides regular reporting to the IFB Quality Assurance Head.
Commissioning, Qualification & Validation:
Supports the development, implementation, and assurance of quality management system within IFB.
Supports the execution of the project C&Q&V strategy, C&Q&V plans, and system impact assessments.
Assists in the preparation and execution of DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and VMP.
Interacts with all relevant interfaces to share benchmarks and best practices.
Responsible for ensuring consistency of turnover packages for system owners.
Project Control, Costs & Schedule:
Supports the regular tracking of actual project costs and progress in quality assurance.
Supports compliance with Sanofi guidelines and standards for cost and scheduling.
Additional Responsibilities:
Promotes quality culture, quality awareness, GMP compliance, and continuous improvement across all functions and organizational levels in the project and at future sites to ensure fulfillment of GMP requirements.
Conducts quality oversight activities in line with IFB planning and project requirements, including drafting, reviewing, and approving documentation.
Acts as the responsible Quality Subject Matter Expert (SME) for the project in all matters of quality assurance, ensures quality compliance throughout project execution.
Actively participates in project team meetings, planning and scheduling sessions, and all related project requirements to ensure effective planning and execution of key quality risk management deliverables.
Supports reporting of key project-related deliverables in quality and ensures timely and effective communication and escalation of quality risks to the appropriate management levels.
Provides mentoring and guidance to IFB team members (project teams) in appropriate quality compliance behaviors, recommends and highlights systematic improvements to leadership.
Develops, updates, and promotes Sanofi’s global quality documentation and global procedures.
Contributes to the digital strategy and transformation through effective communication with the project
About you
Experience
Degree in Science/Pharmacy or Equivalent.
Ideally MSc level qualification in Science.
3-5 years industry experience, preferably within the biopharma and/or related regulated industry.
In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.
Experience: Practical experience in Quality Operation,Quality System Management and quality risk management in Health regulated industry.
Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation,
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:
Driving change
Cross-functional collaboration
Decision-making
People development
Negotiation and influencing skills
Business partnering
Communication skills
Leadership and assertiveness
Technical Skills:
Quality risk management
Quality systems
Continuous improvement management
GxP and health-regulated requirements
International and FDA experience
Languages:
International and FDA experience
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 videoand check out our Diversity Equity and Inclusion actions at sanofi.com!
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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
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How many Healthcare jobs are open in Beijing, China right now?
There are currently 544 open healthcare positions in Beijing, China listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Beijing, China?
Companies currently hiring include Sanofi, IQVIA, Takeda, GE HealthCare, ICON plc, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Beijing, China?
Yes — 108 of the 544 open healthcare positions offer remote or hybrid work (33 remote, 75 hybrid).
How do I apply for Healthcare jobs in Beijing, China?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.