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 a Product Quality Leader, Senior Director.
Scope of the job:
The Senior Product Quality Leader position is responsible for end-to-end Product Quality Strategy for one or more new product classes or modalities (cell therapy, large molecule, and small molecule) or specific technical areas of need (e.g., product or analytical development, CMC strategy) as designated 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 therapeutic products or areas of technical expertise 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.
- Work in close partnership with Manufacturing, Quality, Process Development, Analytical Development, MSAT, Supply Chain, and CMC leadership to ensure platforms or uniform Product Quality standards are adopted, applied and 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 in collaboration with PD, MSAT, AD, and QC (including Stability)
- Provide expert-level assessment of product quality during technical issues that occur during routine manufacturing, and distribution of drug substance (including vector) and drug product material
- Author, review, provide technical support, and approve regulatory documents, filings and communications.
- Serve as a working member of product development and commercialization teams, working to ensure robust process development, design, and commercialization of products under development
- Lead systems and processes and/or governance forums established to provide cross-functional oversight and guidance for CMC teams
- Drive strategic oversight of product quality development deliverables to ensure patient safety, product quality, patient safety, and regulatory success
- Develop end-to-end product quality strategic plan 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 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, including process and analytical development, and CMC strategy.
- As appropriate, mentor and/or advise staff, provide input for appropriate staff during staff reviews
