Global Head of Product Quality - any Galapagos location Leiden,NL

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

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…!