GEM Programming Solutions
Part-Time Quality Assurance Manager
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About GEM
GEM Programming Solutions Ltd is a specialist Biometrics CRO providing statistical programming, data standards, reporting, and regulatory submission support to biotechnology and pharmaceutical companies worldwide. We pride ourselves on delivering high-quality, inspection-ready outputs and maintaining the highest standards of quality, compliance, and customer service.
As our company continues to grow, we are seeking a Part-Time Quality Assurance Manager to support and enhance our Quality Management System (QMS), ensuring the integrity, consistency, and compliance of our data, processes, and deliverables.
GEM Programming Solutions is committed to being a diverse and inclusive workplace. We endeavour to create a work environment where everyone is valued, respected, safe from discrimination, and encouraged to develop new ideas.
The Role
The Quality Assurance Manager will play a key role in maintaining and continuously improving GEM's quality framework. Working closely with the Leadership Team, and clients, you will help ensure that quality standards are consistently applied across projects and internal processes.
This is an excellent opportunity for an experienced quality professional seeking a flexible, part-time position within a growing and highly respected clinical research organisation.
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Key Responsibilities
- Maintain and continually improve GEM's Quality Management System (QMS).
- Monitor quality metrics, trends, deviations, CAPAs, and quality risks.
- Conduct, coordinate and support internal audits and supplier qualification activities.
- Assist with client audits and regulatory inspections.
- Create and review quality-related documentation, SOPs, work instructions, templates, and forms.
- Ensure document control processes remain effective and compliant.
- Support implementation of data integrity and quality standards.
- Investigate quality issues and assist with root cause analysis and corrective actions.
- Support training activities and promote a culture of quality throughout the organisation.
- Participate in continuous improvement initiatives across business processes.
Essential Qualifications & Experience
- Degree in a scientific, life science, quality, or related discipline.
- Previous experience in Quality Assurance, Quality Management, or Data Quality within a regulated environment.
- Strong understanding of GxP, ICH-GCP, and quality management principles.
- Experience working within the pharmaceutical, biotechnology, CRO, or healthcare sectors.
- Excellent attention to detail and organisational skills.
- Strong document review and written communication skills.
- Ability to work independently and manage multiple priorities.
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Desirable Experience
- Experience supporting FDA, EMA, MHRA, or other regulatory inspections.
- Knowledge of computerized system validation (CSV) and data integrity principles.
- Experience with GxP / ISO-based quality systems.
- Familiarity with clinical trial processes, statistical programming, data management, or CDISC standards.
- Experience with risk management methodologies and CAPA processes.
Personal Attributes
- Highly organised and detail oriented.
- Pragmatic and solutions focused.
- Strong interpersonal and communication skills.
- Able to influence stakeholders positively and drive continuous improvement.
- Comfortable working in a remote, collaborative environment.
What We Offer
- Flexible part-time working arrangement.
- Fully remote working.
- Opportunity to work with a highly experienced and supportive team.
- Involvement in cutting-edge clinical research programmes.
- Competitive salary commensurate with experience.
- Opportunity to make a significant impact within a growing specialist CRO.
How to Apply
Please include your CV as part of the LinkedIn Application Process.
Start Date: September/October 2026
Deadline: 31st July 2026
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