Associate Director Global 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’.

We are seeking a highly motivated Associate Director to lead the Operations team within Global Quality Control which is located in Leiden , The Netherlands. The QC Operations team is responsible for testing release, characterization, product monitoring, stability and comparability samples of our drug product as well as testing patient samples for monitoring (post infusion) and incoming goods for release. The laboratories are expected to operate and maintain cGMP standards. The team is also responsible for the management of samples and our network of third-party outsourcing laboratories.

In this role, you are responsible for leading a team of managers and technicians while defining a clear strategy, implementation of new processes and improvements on existing processes applicable to central and global activities. You should be able to think strategically ahead and have hands-on experience in Quality Control, its compliance and regulatory requirements.

Your role

• Lead the QC Labs Operations and Sample Management teams using hands-on expertise to provide guidance on compliance, quality control processes and prioritization
• Define and implement the short-term and long-term strategy for the processes related to testing and sample management for central and global activities in conjunction with different stakeholders
• Define and implement activities to ensure cGMP compliance for testing, reviewing and reporting
• Collaborate cross-functionally to optimize existing or new processes for compliance and ensuring
• Lead and execute risk assessments, as needed
• Write, review or approve procedures, protocol, and reports
• Ensure timely closure of quality and training records to meet the company’s KPIs
• Support compliance related topics; deviations, CAPAs, change controls, etc.
• Support regulatory filings and health authority questions, including inspections
• Ensure adequate resources are available for defined activities

Who are you?

• BSc or MSc degree in Life Sciences, Biotechnology, related discipline
• 8-10 years of work experience in the pharmaceutical or biotech industry in quality control
• Demonstrated experience at people management
• Experience at building and managing new and growing teams
• Experience at defining risk-based short and long term strategies
• Knowledge of analytical techniques such as flow cytometry, PCR or biological assays preferred
• Advanced understanding of cGMPs, EU and US regulations
• Previous experience in setting an operationally compliant quality control laboratory and processes preferred
• 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

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.

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.

We are Galapagos: together we make it happen…!