Medical Device QA Manager jobs

Bodyline Medical Wellness Clinics is a leading CQC-registered clinical services and clinical research group with nearly 20 years of experience delivering patient-centred, medically supported health programmes. With seven clinics across the Northwest and a nationwide telehealth service, Bodyline specialises in obesity, metabolic and female health — offering GLP-1 weight management, hormone replacement therapy, and diagnostic health services.

As part of our continued growth and commitment to innovation, accessibility and improved health outcomes across the UK, Bodyline has expanded through a dedicated Clinical Research Trial Services and is recruiting a Quality & Compliance Manager. As the successful roleholder you would be responsible for establishing, maintaining and continuously improving the Quality Management System (QMS) across Bodyline Clinic’s clinical research operations.

This role is a part time opportunity to work 2/3 day per week from our Head Office in Disley and from our clinics based in the Openshaw, Warrington, Stoke, St Helens and Crosby.
You will be reporting to the Head of Clinical Research Operations & Business Development.

You will ensure compliance with ICH-GCP, UK Clinical Trial Regulations, MHRA requirements, sponsor expectations and Bodyline policies and procedures. The role will provide independent quality oversight across all research activities, supporting operational excellence, inspection readiness and a culture of continuous improvement.

As Bodyline continues to expand its clinical research portfolio across obesity, metabolic disorders, diabetes, women’s health and other therapeutic areas, the Quality & Compliance Manager will play a critical role in safeguarding quality standards and ensuring the organisation remains audit and inspection ready.

Key responsibilities

Quality Management System (QMS)

• Lead the development, implementation and maintenance of the Bodyline Quality Management System.
• Ensure all policies, SOPs, work instructions, templates and quality documents remain current and compliant.
• Maintain document control processes and version management.
• Establish and manage quality governance processes across all sites.
• Drive continuous improvement initiatives throughout the organisation.
• Ensure all quality systems remain aligned with regulatory requirements and industry best practice.

Regulatory Compliance and GCP Oversight

• Ensure compliance with:
• ICH-GCP
• UK Clinical Trial Regulations
• MHRA Guidance
• Sponsor and CRO requirements
• Data Protection Regulations
• Internal Bodyline procedures
• Monitor adherence to protocol requirements and site procedures.
• Identify compliance risks and implement mitigation strategies.
• Provide guidance and support to operational teams regarding quality and compliance matters.
• Escalate significant compliance concerns to senior leadership.

Audit & Inspection Management

• Develop and maintain the annual internal audit programme.
• Conduct routine site audits and process audits.
• Perform study-specific audits where required.
• Coordinate sponsor, CRO and regulatory inspections.
• Support inspection readiness activities across all research sites.
• Lead audit preparation, hosting and follow-up activities.
• Monitor audit findings and ensure timely resolution.

CAPA Management

• Manage quality issues, deviations, non-conformances and compliance concerns.
• Facilitate Root Cause Analysis investigations.
• Develop, implement and monitor Corrective and Preventive Action (CAPA) plans.
• Ensure CAPAs are completed within agreed timelines.
• Assess effectiveness of CAPAs and monitor recurring trends.
• Produce quality trend analysis and recommendations.

Training & Competency Management

• Maintain organisation-wide training compliance.
• Manage the Bodyline training matrix.
• Ensure all staff maintain mandatory GCP and role-specific training requirements.
• Support competency assessments across all clinical research roles.
• Deliver quality and compliance training where required.
• Support onboarding and induction programmes from a quality perspective.

Risk Management

• Lead quality risk assessments across operational processes.
• Support implementation of risk-based quality management principles.
• Identify emerging risks and implement mitigation plans.
• Maintain organisational risk registers related to quality and compliance.
• Support business continuity planning and quality resilience initiatives.

Vendor & Supplier Oversight

• Support qualification and approval of vendors and suppliers.
• Participate in vendor assessments and audits.
• Ensure critical service providers meet quality and regulatory expectations.
• Maintain vendor qualification documentation and records.

Quality & Metrics reporting

• ·Develop and maintain quality performance indicators.
• Produce monthly quality reports for senior leadership.
• Analyse and report trends relating to:
• Protocol deviations
• CAPAs
• Training compliance
• Audit findings
• Inspection readiness
• Data quality issues
• Quality events
• Present quality updates to senior leadership teams.

Inspection readiness

• Maintain a state of continuous inspection readiness.
• Support MHRA inspections and sponsor audits.
• Lead inspection preparation activities.
• Coordinate responses to inspection findings.
• Ensure implementation and monitoring of inspection-related CAPAs.

Key Performance Indicators (KPI’s)

• SOP Review Compliance ≥ 95%
• Training Compliance ≥ 95%
• CAPA Closure Within Timelines ≥ 90%
• Internal Audit Programme Delivery 100%
• Inspection Readiness Maintained Across All Sites
• Reduction in Repeat Quality Findings
• Reduction in Protocol Deviations
• Monthly Quality Metrics Delivered On Time
• Vendor Qualification Compliance ≥ 95%

Qualifications and experience

Essential

• Degree in Life Sciences, Healthcare or related discipline.
• Minimum 3 years' experience in Clinical Research Quality Assurance, Clinical Operations or Regulatory Compliance.
• Strong knowledge of ICH-GCP and UK Clinical Trial Regulations.
• Experience conducting audits and quality reviews.
• Experience managing CAPAs and quality investigations.
• Strong understanding of clinical trial processes within research sites, CROs or sponsors.
• Excellent written and verbal communication skills.

Desirable

• MHRA inspection experience.
• Research Site, CRO or Sponsor quality experience.
• Lead Auditor qualification.
• Experience implementing or managing Quality Management Systems.
• Experience within obesity, metabolic, diabetes or women's health research.

Skills and Competencies

• Strong attention to detail.
• Excellent organisational skills.
• Effective problem-solving and decision-making abilities.
• Ability to work independently and influence stakeholders.
• Strong analytical and reporting skills.
• Excellent interpersonal and communication skills.
• Risk-based thinking and quality-focused mindset.
• Ability to build a positive quality culture across multiple sites

Pay: £40,000.00-£45,000.00 per year

Benefits:

• Company events
• Employee discount
• Free parking

Ability to commute/relocate:

• Stockport SK12 2AE: reliably commute or plan to relocate before starting work (preferred)

Education:

• Bachelor's (preferred)

Experience:

• Clinical Research QA/Clinical Ops/Regulatory Compliance: 3 years (required)

Language:

• English (preferred)

Work authorisation:

• United Kingdom (required)

Location:

• Stockport SK12 2AE (preferred)

Work Location: Hybrid remote in Stockport SK12 2AE