Cryoport Systems
Life Sciences
QA/RAManager
Neural analysis suggests this role is
optimal for Manager candidates.
“QA/RA Manager at Cryoport Systems. Skills: Quality Assurance, Regulatory Affairs, Compliance, QMS. Manage a small team. Ensure implementation of Local QMS”
What You'll Achieve.
Ensure alignment; Ensure compliance; Ensure continuous improvement; Ensure timely integration; Ensure alignment with global QMS; Ensure compliance with internal procedures; Ensure compliance with applicable regulations; Guarantee appropriate documentation; Guarantee investigation; Guarantee closure; Ensure high level of readiness; Drive successful outcomes; Strengthen processes; Maintain high standards of quality; Maintain high standards of compliance; Ensure processes are properly implemented; Ensure analytical methods are properly implemented; Ensure systems are properly implemented; Ensure processes are properly documented; Ensure analytical methods are properly documented; Ensure systems are properly documented; Ensure processes are understood; Ensure analytical methods are understood; Ensure systems are understood; Ensure alignment; Share knowledge; Support global quality initiatives; Support global regulatory initiatives
Industry & Context.
Risk assessment; Impact assessment
On-site presence expected, 4/5 working schedule considered
What They're Looking For.
Must Have
5+ years exposure, Academic background in Life Sciences, Solid understanding of quality and regulatory requirements, Command of GMP principles, Deep knowledge of Belgian and European regulations, Structured and analytical mindset, Ability to anticipate risks, Ability to assess impacts, Ability to prioritize effectively, Ability to translate complex regulatory frameworks, Work autonomously, Sense of ownership and accountability, Solution-oriented approach, Comfortable interacting with multiple stakeholders, Fluent in English (minimum B2 level)
Nice to Have
Experience in pharmaceutical, biotech, or CDMO environments, Experience within Quality Assurance or Regulatory roles, Experience within Human Body Material regulations
What You'll Do.
Ensure implementation of Local QMS
Monitor performance through KPIs
Conduct internal audits
Conduct management reviews
Maintain compliance with Belgian and European regulations
Monitor regulatory developments
Assess regulatory impact
Integrate regulatory requirements
Develop local quality documentation
Review local quality documentation
Implement local quality documentation
Oversee product quality
Oversee release activities
Monitor product performance
Monitor process performance
Manage change controls
Assess quality impacts
Assess validation impacts
Document investigations
Investigate deviations
Act as point of contact for regulatory inspections
Act as point of contact for customer audits
Ensure readiness for inspections
Coordinate internal stakeholders for audits
Drive successful audit outcomes
Support training program deployment
Support training program effectiveness
Implement global training locally
Develop complementary training modules
Monitor training performance
Drive continuous improvement
Leverage quality metrics
Leverage audit findings
Leverage customer feedback
Provide QA support to operations
Ensure processes are implemented
Ensure analytical methods are implemented
Ensure systems are implemented
Ensure processes are documented
Ensure analytical methods are documented
Ensure systems are documented
Ensure processes are understood
Ensure analytical methods are understood
Ensure systems are understood
Contribute to planning activities
Contribute to scheduling activities
Collaborate with Global QA/RA teams
Collaborate with cross-functional stakeholders
Support global quality initiatives
Support global regulatory initiatives
How You'll Work.
Team & Collaboration
Local operations and global QA/RA; Cross-functional stakeholders; Operational teams; Global functions
Full Job Description
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 providi
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