Interim Quality Assurance Consultant/Manager – BioChek
Day/hourly Rate: Competitive
Introduction
Cranleigh STEM is partnering with BioChek to appoint an Interim Quality Assurance Consultant to support the business through a critical transition period and site relocation project.
This contract assignment requires an experienced QA professional to provide specialist quality and compliance expertise on a defined project basis. The successful consultant will take ownership of reviewing, improving and embedding key quality systems and processes, ensuring the organisation maintains compliance and operational effectiveness throughout a period of change.
The Assignment
Working closely with senior leadership and cross-functional teams, you will lead quality-focused project activities relating to QMS enhancement, compliance readiness and operational improvement.
You will act as a subject matter expert across quality assurance and compliance, supporting the business in strengthening systems, driving continuous improvement and maintaining ISO and GMP standards during a key growth phase.
Scope of Work
- Review, enhance and maintain the existing Quality Management System (QMS)
- Support ongoing compliance with ISO9001 and GMP requirements
- Lead quality and compliance activities associated with the site transition project
- Review and improve document control processes, record management and archiving systems
- Manage non-conformance, deviation and CAPA activities
- Plan and conduct internal audits and support external audit readiness
- Identify and implement continuous improvement opportunities across QA processes
- Provide QA guidance and support to cross-functional stakeholders
- Produce and present quality metrics, reports and compliance updates to leadership teams
- Support customer complaint investigations and resolution activities
- Deliver training and coaching relating to quality systems and compliance best practice
Experience Required
- Proven track record delivering QA projects within regulated environments
- Strong working knowledge of ISO9001 and GMP quality systems
- Previous experience supporting business change, transition or improvement projects
- Internal auditing experience
- Ability to work independently and provide expert QA guidance
- Strong stakeholder management and communication skills
- Analytical and process-improvement focused mindset
- Strong organisational skills with excellent attention to detail
- Proficient in Microsoft Office applications
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