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Head of Supplier 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 Head of Supplier Quality - any Galapagos location



Scope of the role

The Head of Supplier Quality position is responsible for oversight, qualification and collaboration with external GxP suppliers. The scope of the role includes all modalities (including cell therapy, small molecule) in the Galapagos portfolio, with an emphasis on suppliers who provide critical materials or services to GxP manufacturing/testing/distribution conducted in support of products at mid-stage (and beyond) stage of development. The Decentralized Manufacturing Units (DMUs) supporting our Cell Therapy drug product manufacturing network are not in scope for this role.


Your role

  • Lead and direct all aspects of driving effective quality and GMP compliance performance at key suppliers, as defined in the scope, to ensure high levels of patient safety, product quality, and regulatory success are routinely met for Galapagos products.
  • Ensures fundamental Supplier Quality program elements are in place and being effectively used, including risk-based processes for Supplier Qualification, Complaint management, and managing Supplier Initiated Changes.
  • Drive generation, utilization and maintenance of Quality Agreements and other appropriate governance mechanisms.
  • Leverage processes to understand risk profile for key suppliers, with mitigation plans in place and effectively managed as appropriate.
  • Ensure collaborative leadership and productive Quality-to-Quality relationships are in place with key suppliers, to effectively and jointly monitor performance against agreed targets, to manage risks to product quality and GMP compliance in a timely manner, and to ensure product and supply changes are managed openly and effectively.
  • Drive jointly agreed improvement projects to maintain and enhance the performance standards necessary to achieve Galapagos’ ambitions.
  • Ensure effective processes are established and utilized for effective issue resolution, to include appropriate escalation mechanisms as needed.
  • Work cross-functionally in Galapagos (e.g., other Quality functions, Manufacturing, Supply Chain, MSAT, PD/AD) to understand and respond as needed to performance-related observations, upcoming changes, and emerging risks for suppliers.
  • Work with GMP Audit function to support generation of a risk-based audit schedule, and to ensure key areas of concern or risk are addressed in supplier audits.
  • Author, review, and provide technical support as needed for investigations, change controls, and regulatory documents, filings and communications.
  • Staff, lead and deploy a team of Supplier Quality professionals with the appropriate level of capability to ensure the above responsibilities are carried out effectively.
  • Ensure growth in capabilities and professional development of staff members on the Supplier Quality team.

Job requirements

Who are you

  • Science degree preferred–– with at least 12 years’ experience in pharmaceutical/biopharmaceutical manufacturing and quality operations
  • Demonstrated technical understanding of development and commercialization supply chains for ATMP products (strongly preferred) and/or other biotechnology/large molecule products.
  • Experienced in Supplier Quality management processes, including Quality Agreements, and fundamental GMP compliance processes.
  • Able to travel for face-to-face interaction with suppliers and other global partners up to 25-30% of your time.
  • Demonstrated capability in strategy development and deployment, risk management, change/stakeholder management and business improvement processes.

Demonstrated cross-functional/inter-disciplinary knowledge (e.g., Manufacturing, Quality Control, Procurement, PD/AD, other Quality and Supply chain functions).

  • Able to lead change programs involving stakeholders at all levels across different companies, functions, and regions in a highly regulated environment
  • Experienced with people management and organizational leadership.

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
  • Experienced in reviewing and providing technical input support to product quality and documents and regulatory filings
  • Demonstrated leadership skills across functions and organizational levels, with ability to engage and motivate a matrix team of professionals.
  • Understand Business Development activities from a Quality perspective.
  • Strong people leader to engage, motivate and develop productivity in 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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