Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.
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, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.
We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.
We are looking for Product Quality Leader, Director.
Scope of the job:
The Product Quality Leader position is responsible for end-to-end Product Quality Strategy for individual products across all modalities (cell therapy, large molecule, and small molecule) that they are designated to have responsibility for by the Global Head of Product Quality. Scope of responsibilities include from pre-clinical/clinical FIH stage through pivotal clinical trials and commercial filing, approval, and launch, to ensure the right end to end quality plan is developed to support accelerated and robust supply to patients.
Your role:
- Ensure Product Quality oversight of designated therapeutic products and where applicable, critical raw materials (including plasmid and vector within cell therapy modality), drug substance, intermediates, drug products, finished labeled drug product, stability, and method validation / transfer activities. For products designated to this individual, they will:
- Work in partnership with Manufacturing, Quality, Process Development, Analytical Development, MSAT, Supply Chain, and CMC leadership to ensure Product Quality standards are met and in compliance with applicable regulatory requirements and specifications
- Provide product quality oversight and strategic input over product and analytical development, characterization, tech transfer, comparability, and validation studies conducted for designated products in collaboration with PD, MSAT, AD, and QC (including Stability)
- Ensures impact to product quality is thoroughly assessed during development, routine manufacturing, and distribution of drug product material
- Authors, reviews, provides technical support, and approves regulatory documents, filings and communications.
- Will be a member of product-specific development and commercialization teams, working to ensure robust process development, design, and commercialization of designated products under development
- Develop end-to-end product quality strategic plan for designated products with clear ownership for each deliverable with Process Development, Analytical Development, Manufacturing Science & Technology (MSAT), Quality Control, Supply Chain, Regulatory and CMC / Commercial Leaders
- Facilitate new product development issue resolution and the timely advancement of designated new products to ensure they are filed and launched on time.
- Supports the Global Head of Product Quality in providing guidance on new product development
- As appropriate, mentor and/or advise staff, provide input for appropriate staff during staff reviews
