Quality Assurance Manager

JR United Kingdom; Milton Keynes; On-site; GBP 45,000 - 70,000; Full time

Job summary

A leading company in clinical research is seeking a Quality Assurance Manager to oversee the quality management system. This role is crucial for maintaining high standards in quality assurance and compliance within clinical trials, requiring extensive experience and additional skills in governance and risk assessment.

Qualifications

• Minimum 8-10 years experience in clinical research according to GCP.
• At least 2 years in a Quality Assurance role within a GCP-regulated environment.
• Very good knowledge of GCP principles and regulatory requirements.

Responsibilities

• Assist in the development and implementation of Good Clinical Practice oversight.
• Conduct audits and follow up on corrective actions.
• Supervise SOP revisions and ensure compliance with GCP.

Skills

Excellent command of written and spoken English

Ability to work independently

Skilled in advising team on quality and compliance matters

Ability to familiarize oneself with specific indications and study designs

Very good knowledge of standard office software

Education

University or college degree in a medical or life-sciences related field

Job description

Social network you want to login/join with:

Quality Assurance Manager, milton keynes

col-narrow-left

Client:

Linical

Location:

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

6

Posted:

31.05.2025

Expiry Date:

15.07.2025

col-wide

Job Description:

Quality Assurance Manager - Europe

Full-time

Home-based in EU

The Manager of Quality Assurance is a quality professional within Linical responsible for assisting in the development and implementation of risk-based Good Clinical Practice oversight within Linical processes. This includes identification of risks, communication of risks to the organization, and working in a cross-functional team setting to mitigate the risks.

Duties and Responsibilities:

• Support the Quality Assurance department in maintaining Linical’s Quality Management System (QMS) for all Linical services including:
• Conduct of audits (systems, documents, TMF, clinical sites, vendors)
• Follow-up of corrective and preventative actions (CAPA) and deviations
• Supervision of SOP revisions
• Review of SOPs in cooperation with the operational staff to ensure compliance with GCP and regulatory requirements
• SOP-management (access control, notification of employees, tracking, etc.)
• Vendor qualification and management of related documentation
• Improving of standard and process for quality and efficiency
• Computer system validation/verification
• Provide support prior to and during regulatory inspections by authorities and audit performed by Sponsors on Linical
• Consultancy for operational staff in quality, procedural, and regulatory related questions
• Administrative tasks related to the maintenance of the QMS of Linical

Required Skills and Abilities:

• Excellent command of written and spoken English
• Ability to work independently and build strong, trusting working relationships with all departments and clients
• Skilled in advising team on quality and compliance matters
• Ability to familiarize oneself with specific indications, symptoms, and study designs
• Very good knowledge of standard office software

Education and Experience:

• University or college degree (or equivalent) in a medical or life-sciences related field
• Minimum 8-10 years experience in clinical research according to GCP with at least 2 years in a Quality Assurance role within a GCP-regulated environment
• Very good knowledge of GCP principles and related US, European, and other international regulatory requirements for the conduct of clinical trials
• Practical auditing experience
• Practical experience managing SOPs and the revision lifecycle