Quality Systems Lead (Pharmaceutical)

TL;DR

Quality Systems Lead (Pharmaceutical): Managing Quality Assurance and QMS for vaccine production in accordance with GXP guidelines with an accent on regulatory compliance, event management, and digital archiving. Focus on tracking CAPAs, ensuring GDPR compliance, and optimizing quality processes within a matrix environment.

Location: Netherlands. Hybrid work is encouraged for those within a reasonable commute of the office; remote work is supported.

Company

A professional services firm providing end-to-end consulting and expertise to biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Act as the QA lead for MCM Vaccine B.V. in accordance with GMP, GDP, and GVP guidelines.
• Manage the SciLife electronic Quality Management System to ensure archiving and traceability of documentation.
• Track event management, including deviations, changes, and complaints.
• Oversee Corrective Actions and Preventive Actions (CAPAs) to ensure timely completion.
• Lead EU GDPR compliance for all internal processes.
• Collaborate with stakeholders to ensure JV processes maintain an appropriate quality level.

Requirements

• 3-5 years of experience in QA, QMS, or validation within the pharmaceutical or biotech sector.
• Must be based in the Netherlands or within commuting distance of the office for hybrid collaboration.
• Bachelor's degree qualification or equivalent (e.g., BSc/BTech).
• Proven track record of working within GXP environments.
• Strong communication, project management, and interpersonal skills.

Culture & Benefits

• Commitment to diversity, equity, and inclusion, fostering an environment where employees can be their authentic selves.
• Flexible work arrangements supporting both remote and hybrid models.
• Human-centric hiring process with personal reviews of all applications (no AI screening).
• Collaborative and entrepreneurial company culture.