Product quality leader, Senior Director - Leiden (NL) or Princeton, NJ (USA)

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

Who are you?

EDUCATION AND EXPERIENCE

• Science degree – post graduate degree (MS or PhD) preferred – with at least 14 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
• New product development/tech transfer/comparability experience
• 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.

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

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

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.