Quality Manager Operations Asia (Contractor - 6 months)

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We are looking for a Quality Manager Operations Asia, to join our team as a contractor for a 6 months period.

Project Scope

Help bring CAR-T therapies to patients across Asia – Lead the expansion of decentralized manufacturing!

We're seeking a driven expert (contractor) to support the rollout of Decentralized Manufacturing Units (DMUs) across Asia, making life-changing CAR-T treatments accessible in more regions. You’ll lead the end-to-end qualification and onboarding of multiple DMU sites – from early site selection through to clinical readiness. In China, your scope will also include strategic oversight of manufacturing for Investigator-Initiated Trials (IIT) and Lentiviral Vector (LVV) production.

Your mission

• Support qualification and onboarding of manufacturing sites, CROs, central labs, and clinical sites.

• Perform quality auditing and monitoring of manufacturing sites, CROs, central labs, and clinical sites.

• Drive compliance development for manufacturing sites, CROs, central labs, and clinical sites to enhance quality consistency.

• Provide performance oversight for point-of-care manufacturing partners by developing a digital quality oversight system (DMUs), aligned with Chinese, EU, and US regulatory guidelines.

• Conduct audits and ensure quality oversight at IIT sites when major or critical deviations or SAEs occur related to ATMP manufacturing.

• Review batch records to ensure data integrity and compliance.

• Act as Person-in-Plant during batch production when required.

• Conduct audits and provide quality oversight at LVV manufacturing sites in case of critical deviations related to LVV manufacturing.

Working relationships: Frequent interaction with Site Management Cell Therapy (Managers and Head), Point-of-Care Operations (Process Engineers to Directors), QC Cell Therapy (Scientists to Head), and Systems & Technology teams (Engineers, Leads, Head).

Who are you?

-Relevant master’s degree

-At least 7 years of experience in a senior role within a GMP environment with thorough working knowledge of cGMP QA processes.

-Knowledge of GCP regulations is a plus.

-Experience in IIT setting is a plus.

-Proficient in project management is a plus.

-Experience in a clinical and commercial GMP manufacturing setting

-Fluency in English and Chinese

-Good interpersonal skills and written and spoken

General skills:

-Able to travel for on-site visits (monitoring / audit etc) to IIT / LVV production sites / Clinical sites for F2F interaction with stakeholders, up to 25% of the time.

-Able to work in a fast-paced small company environment with minimal direction and are able to adjust workload based on changing priorities

-Result-driven and can-do mindset, without compromising quality and compliance

-Experience in GMP manufacturing of LVV and ATMP is a plus

-Auditing experience

-Cross functional alignment with internal and external stakeholders

-QA review of QC method transfers for characterisation of Cell Therapy products.

-Able to navigate regulatory requirement for early clinical phases and later phases of clinical trials.

-Prefered location: Beijing.

What's in it for you? 

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.

To streamline our hiring process, we kindly request that only individual freelancers and our preferred vendors submit CVs directly to us. Applications sent by non-preferred agencies, recruitment firms, or other third parties on behalf of freelancers will not be considered. This approach helps us maintain an efficient and direct connection with top talent, ensuring a smooth experience for all involved.