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Global Head of Product Quality - any Galapagos location

Princeton, United States; 's-Graveland, Netherlands

Job description

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 expanding our US footprint to set-up our decentralized CAR-T network and further build our research capabilities in the US.



We are currently looking for a
Global Head of Product Quality - any Galapagos location



SCOPE OF THE ROLE

The VP Global Product Quality position is responsible for end-to-end Product Quality Strategy for new products across all modalities (cell therapy, large molecule, and small molecule) from pre-clinical/clinical FIH through pivotal clinical trials and commercial filing, approval, and launch for all assets under development to ensure the right end to end quality plan is developed to support accelerated and robust supply to patients.


YOUR ROLE

  • Leads and directs all aspects of the Global Product Quality function, ensuring Product Quality oversight of 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.
  • Works 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
  • Provides 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)
  • 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 core member of the product development and commercialization forum(s) established to ensure robust process development, design, and commercialization of all products under development
  • As needed, establishes systems and processes and/or governance forums to provide cross-functional oversight and guidance for CMC teams
  • Lead team of Product Quality Leaders with the right capabilities to 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.
  • Serves as the global resource to the Quality Organization to provide guidance on new product development
  • Lead, mentor, and/or advise staff, provide input for appropriate staff during staff reviews

Job requirements

Who are you?

  • Science degree – post graduate degree (MS or PhD) preferred – with at least 17 years’ experience in pharmaceutical/biopharmaceutical manufacturing and quality operations
  • Strong knowledge of CMC and Quality requirements with ability to explain these and relate to manufacturing operations
  • Extensive knowledge of the pharmaceutical/biopharmaceutical industry with particular focus on the development and manufacturing of medicinal products including cell therapies
  • Experience in strategy development and deployment, change/stakeholder management and business improvement
  • Demonstrate cross-functional inter-disciplinary knowledge.
  • Able to ensure delivery of change programs involving stakeholders at all levels across different functions, regions and cultures in a highly regulated environment
  • Excellent knowledge of CMC development strategy and operations
  • New product development/tech transfer/comparability experience
  • Proven experience working in strategic end-to-end collaboration with Process Development, Analytical Development, Manufacturing, Technical Operations, Regulatory, and Commercial functions
  • Experience having worked at the interface R&D/manufacturing and able to challenge R&D and CMC teams.
  • Experience in new modalities (e.g. immune-oncology, human genetics, cell and gene therapy).

GENERAL SKILLS

  • Proficiency with application of ICH Quality Guidelines, cGMP’s, CFR’s, EC/JP GMPs for cell therapies within the appropriate clinical or commercial environment
  • Skilled in authoring, reviewing/approving and providing technical support to regulatory filings (IND/IMPD/BLA/MAA/etc.)
  • Demonstrated leadership skills across functions and organizational levels, with ability to engage and motivate a team of professionals.
  • Understand Business Development activities from a Quality perspective.
  • Strong people leader to engage and motivate a team of professionals.


What’s in it for you ?

You will be part of a fast growing and amazing company and member of the Business Development team. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.


We are Galapagos : together we can make it happen…!

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