QA/RA Manager

Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™  by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.

As a Freelance QA Manager, you will be responsible for leading the local Quality Assurance function and ensuring that all operational activities — including Intermediate Structure activities — comply with:

• International, European, and local regulations (GMP, GDP, GTP, Human Body Material

• Internal Global Quality Management System (QMS)

• Competent Authority and customer requirements

You will act as a key interface between local operations and global QA/RA teams, ensuring alignment, compliance, and continuous improvement.

KEY RESPONSIBILITIES

• Responsible for managing a small team of at least 4 employees

• Ensure the effective implementation and continuous improvement of the Local Quality Management System by translating global standards into operational practices, while monitoring performance through KPIs, internal audits, and management reviews.

• Maintain full compliance with Belgian and European regulatory requirements by actively monitoring regulatory developments, assessing their impact, and ensuring their timely integration into local processes and quality standards.

• Develop, review, and implement local quality documentation where needed, ensuring alignment with global QMS requirements and providing clear, practical guidance to operational teams.

• Oversee product quality and release activities by ensuring compliance with internal procedures and applicable regulations, while continuously monitoring product and process performance through reviews and trend analysis.

• Ensure proper management of deviations, CAPAs, and change controls by assessing quality and validation impacts, and guaranteeing appropriate documentation, investigation, and closure in line with regulatory expectations.

• Act as the primary point of contact for regulatory inspections and customer audits, ensuring a high level of readiness, coordinating internal stakeholders, and driving successful outcomes.

• Support the deployment and effectiveness of training programs by implementing global training locally, developing complementary modules when required, and monitoring performance through KPIs and audits.

• Drive continuous improvement by leveraging quality metrics, audit findings, and customer feedback to strengthen processes and maintain high standards of quality and compliance.

• Provide ongoing QA support to operations by ensuring that processes, analytical methods, and systems are properly implemented, documented, and understood, while contributing to planning and scheduling activities when needed.

• Collaborate closely with Global QA/RA teams and cross-functional stakeholders to ensure alignment, share knowledge, and support global quality and regulatory initiatives.

YOUR PROFILE

• You bring a strong academic background in Life Sciences or equivalent experience, combined with at least 5+ years of exposure to pharmaceutical, biotech, or CDMO environments, ideally within Quality Assurance or Regulatory roles.

• You have a solid understanding of quality and regulatory requirements across the product lifecycle, including a strong command of GMP principles and a deep knowledge of Belgian and European regulations related to Human Body Material.

• You demonstrate a structured and analytical mindset, with the ability to anticipate risks, assess impacts, and prioritize effectively in a complex and regulated environment.

• You are able to translate complex regulatory frameworks into clear, pragmatic, and operational processes that can be easily understood and applied by cross-functional teams.

• You work autonomously with a strong sense of ownership and accountability, while remaining proactive and solution-oriented in your approach.

• You are comfortable interacting with multiple stakeholders, from operational teams to global functions, and contribute effectively to cross-functional collaboration.

• You communicate fluently in English (minimum B2 level), both written and spoken, enabling you to operate confidently in an international environment.

ASSIGNMENT DETAILS

• This is a freelance/interim assignment offered in the context of a temporary replacement, ensuring continuity of the QA function during an extended absence.

• The assignment is expected to run for approximately 10 months, covering the period from September to June, with a handover and onboarding phase starting ideally on July 1st to ensure a smooth transition.

• The position is based in Villers-le-Bouillet (Belgium), with on-site presence expected to support operational proximity and team collaboration.

• A 4/5 working schedule can be considered, depending on the candidate’s availability and business needs.