At mdgroup, we provide patient-related services that support participants in clinical trials across the pharmaceutical and clinical research industry. We are looking for a Senior Quality & Compliance Officer – GCP & Audit (Remote) to join our Compliance team and play a key role in supporting our quality management system, audit programme, GCP compliance activities, and continuous improvement initiatives.
This is an excellent opportunity for an experienced quality and compliance professional who enjoys working in a global, regulated environment and can apply GCP and quality requirements in a practical, business-focused way.
As a Senior Quality & Compliance Officer you will:
- Support the Compliance Director in establishing and maintaining the QMS (ZenQMS, Q-Pulse/Ideagen)
- Provide practical guidance to the business on GCP regulations, ICH guidelines, and quality requirements
- Conduct risk-based internal audits and support supplier audit activities
- Host and facilitate external client audits and regulatory inspections
- Manage quality and compliance issues, including deviations, complaints, risk assessments, and CAPAs
- Deliver GCP and quality-related training to internal teams
- Work collaboratively with stakeholders to support continuous improvement of quality standards
- Support trend analysis and contribute to annual quality reporting for executive management
What We’re Looking For:
- Strong working knowledge of GCP, ICH guidelines, QMS, and ISO standards
- Experience conducting or supporting internal audits, supplier audits, client audits, or regulatory inspections
- Experience with CAPA, deviations, complaints, risk assessments, and quality issue management
- Ability to make sound, risk-based decisions that align with regulatory requirements while considering business needs
- A pragmatic, business-facing approach to quality and compliance
- Strong written and verbal communication skills
- A collaborative, approachable style and comfort working within a small global team
- Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook
- Degree in a relevant field such as Life Sciences, Quality Management, Regulatory Compliance, or similar
Why Join mdgroup?
- Be part of a global team providing clinical solutions that support patients participating in clinical trials
- Contribute to the continued development of quality and compliance practices across a global clinical services business
- Work with a collaborative, supportive, and knowledgeable compliance team
- Gain exposure to GCP, ISO, audit, inspection, CAPA, risk management, and continuous improvement activities
- Competitive benefits package including: 25 days holiday per year plus public holidays, Birthday, Wellness days, Private healthcare
Ready to Make an Impact?
If you are ready to play a key role in quality and compliance within a global clinical services organisation, we would love to hear from you. Apply today and help us support high standards across the clinical trials we serve.
About Us:
mdgroup is a global clinical solutions company, providing patient related services to support participants in clinical trials for the pharmaceutical and clinical research industry. The Company was established in 2002 and has Headquarters in London (Global HQ) and Durham, NC (US HQ).
Equal Opportunities:
We are committed to promoting equality of opportunity for all employees and job applicants. In line with the Equality Act 2010, we strive to create and maintain a working environment in which everyone is able to make the best use of their skills, free from discrimination or harassment, and in which all decisions are based on merit. No person is subjected to any less favourable treatment on any discriminatory grounds on the basis of age, disability, gender reassignment, marital or civil partner status, pregnancy and maternity, race, colour, nationality, ethnic or national origin, religion or belief, sex or sexual orientation.
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