Associate Director QC Operations- Leiden (NL)
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. 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’.
For our Cell & Gene Therapy organization in Leiden/NL, we are seeking a highly motivated Associate Director to lead the QC Lab Operations and QC Support teams.
Scope of the job
As our Associate Director QC Operations, you lead the QC Lab Operations and QC Support teams. You will provide direction on the strategy and the different processes for which each team is responsible. The QC Lab Operations team amongst other things, is responsible for testing drug product, characterization, product monitoring, immune monitoring and incoming goods samples. The QC Support team is responsible for the lifecycle of equipment, sample management and maintaining the laboratories.
- Lead the QC Lab Operations and QC Support teams, using hands-on expertise to provide guidance on compliance, the different processes and prioritization
- Define and implement the short-term and long-term strategy for the processes related to testing (internal), the maintenance of the laboratories, equipment lifecycle and sample management
- Lead the activities related to GMP readiness of the internal laboratories and processes
- Lead and execute risk assessments, as needed
- Ensure that the processes designed and implemented within the teams are compliant while keeping simple and efficient
- Collaborate cross-functionally to ensure that strategy and processes are aligned and communicated
- Write, review or approve procedures, protocol, and reports
- Support compliance related topics; deviations, CAPAs, change controls, etc.
- Support regulatory filings and health authority questions, including inspections
Who are you?
- BSc or MSc degree in life sciences, biotechnology, or related discipline
- 8-10 years of work experience in the pharmaceutical / biotech industry in a quality control setting
- Demonstrated experience of a mature and coaching people management style
- Experience with equipment lifecycle management, sample management and/or incoming goods preferred
- Experience at defining risk-based short and long term strategies
- Advanced understanding of cGMPs, EU and US regulations
- Strong interpersonal, verbal and written communication skills
- Ability to be flexible with changing priorities
- Self-driven and can-do mindset, without compromising quality
- Fluent in English
- As this role is based in Leiden (NL), you need to be living nearby or willing to relocate to the Netherlands.
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.
We are Galapagos : together we make it happen…!