Claims Quality Assurance Officer, London
Client: DNA Life Sciences
Location: London, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Details
Job Views: 5
Posted: 12.05.2025
Expiry Date: 26.06.2025
Job Description
The responsibilities include:
- Providing QA support across all functions to ensure the success of the company's portfolio and regulatory milestones.
- Reviewing and providing input on quality matters to ensure compliance with regulatory obligations, patient safety, and data integrity during the clinical trial lifecycle.
- Ensuring clinical trials are conducted in accordance with regulatory requirements.
- Managing the company's Quality Management System.
- Setting up and managing audits according to the audit programme, including peer review of audit plans, reports, and findings.
- Managing deviations, investigations, and CAPAs to closure.
- Providing QA-related training tailored to business needs.
- Maintaining QA tracking systems for audits, CAPAs, deviations, and investigations.
- Keeping QA awareness current regarding regulatory changes (e.g., US CFR, EU CTD, ICH).
- Supporting the development and implementation of Veeva QMS modules.
Qualifications
- Degree in life sciences, pharmacy, chemistry, or equivalent.
- Minimum of ten years' experience in the pharmaceutical industry, including early-phase clinical trials, with at least eight years in QA.
- Strong understanding of global regulatory and compliance standards for clinical research.
- Experience with electronic quality management systems like Veeva.
- Excellent communication skills, both visual and interpersonal.
- Experience with regulatory inspections (MHRA, EMA, FDA).
- Involvement in licensing and due diligence activities from a QA perspective.