Freelance/Contract - Quality Systems Lead

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Project

We are currently partnering with a leading life-sciences client who are looking for freelance/contract support for at least one year (likely to extend) on a full time (1.0FTE) basis. This project is to commence immediately; it can be performed largely remotely throughout with occasion trips to the site in the West of the Netherlands. Ideally we are searching for an independent consultant (or an individual willing to work a contract role) who is already based in the Netherlands.

Role Overview

Experienced QA leader responsible for end-to-end quality systems oversight and process validation. Ensures compliance with GMP/GDP/GVP regulations and drives (e)QMS excellence. A successful candidate combines strong technical expertise with excellent collaboration, communication, and stakeholder engagement skills. Fosters quality culture and continuous improvement by building strong cross-functional relationships, providing clear guidance, and fostering alignment across teams.

Key Responsibilities

• Act as QA lead, ensuring compliance with GMP, GDP, GVP, and global regulatory standards

• Own and optimize the (e)QMS, ensuring robust documentation, traceability, and archiving

• Manage quality events, including deviations, CAPAs, change controls, and complaints, ensuring timely resolution

• Perform gap assessments and enhance validation and qualification strategies (DQ/IQ/OQ/PQ, cleaning, transport) using risk-based and lifecycle approaches (e.g., CPV, FMEA)

• Coordinate training activities and maintain high standards of procedures and documentation

• Collaborate cross-functionally with internal and external stakeholders to maintain quality standards

• Drive operational efficiency and continuous improvement initiatives

• Oversee GDPR compliance and manage non-GxP document repositories

Experience & Qualifications

• 5+ years in QA, QMS, or validation roles within pharma/biotech

• Bachelor’s degree in Life Sciences or equivalent

• Strong expertise in:

  • GMP and global regulatory frameworks

  • Process validation lifecycle and continuous process verification

  • QMS implementation and event management

  • Inspection readiness and audits

  • Risk management methodologies (e.g., FMEA)

• Strong communication, stakeholder management, and project management skills

• Proactive, solution-oriented, and effective in a matrix environment

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***