Quality Assurance Manager

JR United Kingdom; Brighton; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company is seeking a Manager of Quality Assurance to assist in developing and implementing oversight of Good Clinical Practice. The role requires extensive experience in clinical research and a strong understanding of compliance and quality systems.

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 related regulatory requirements.

Responsibilities

• Support QA department in maintaining Quality Management System (QMS).
• Conduct audits and follow-up on corrective actions.
• Ensure compliance with regulatory requirements.

Skills

Quality Assurance

Communication

Compliance

SOP Management

Auditing

Education

University or college degree in medical or life-sciences

Tools

Standard office software

Job description

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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