Quality Assurance Manager

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

Job summary

A leading company in clinical research is seeking a Manager of Quality Assurance to oversee their Quality Management System and ensure compliance with regulatory requirements. This role involves conducting audits, managing SOPs, and providing support during regulatory inspections, as well as fostering quality and efficiency improvements within the organization. Candidates must have significant experience in clinical research and GCP, alongside strong communication skills.

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.

Responsibilities

• Support the Quality Assurance department in maintaining the QMS.
• Conduct audits and follow-up on corrective and preventative actions.
• Consultancy for operational staff in quality and regulatory questions.

Skills

Excellent command of written and spoken English

Ability to work independently

Skilled in advising on quality and compliance matters

Ability to familiarize with specific indications

Very good knowledge of standard office software

Education

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

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