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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: United Kingdom

Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position? ̽��ϼ� is seeking a dedicated Director for a QA position within a biotech company!

̽��ϼ� is recruiting for an Associate Director of Clinical QA Compliance to support and oversee the implementation of proactive, risk-based quality strategies within clinical development activities. This role involves ensuring compliance with Good Clinical Practice (GCP) standards, regulatory requirements, and internal quality standards. You will collaborate with cross-functional teams, manage quality risks, and contribute to inspection readiness while fostering a culture of quality within the organization.

Responsibilities:

Develop and implement proactive, risk-based quality strategies for assigned clinical trials.
Collaborate with internal stakeholders to identify and address clinical trial risks, deviations, and quality issues, including root cause analysis and CAPA implementation.
Actively participate in Clinical Trial Teams and Core Teams, providing guidance and reviewing trial documentation.
Maintain inspection readiness by managing quality dashboards, tracking issues, risks, audit findings, and CAPAs.
Interact with external partners, including CROs, to ensure quality oversight of clinical activities.
Support GCP Health Authority inspections, including preparation, facilitation, and follow-up activities.
Organize and oversee internal and external quality audits, ensuring timely completion of CAPAs and effectiveness checks.
Collaborate on the creation and implementation of Quality Agreements with CROs and clinical vendors.
Present relevant quality metrics during stakeholder meetings.
Contribute to continuous improvement initiatives and address identified weaknesses for long-term sustainability.
Mentor team members and promote a culture of transparency, proactivity, and quality excellence.
Author or review procedural documents related to clinical quality aspects as needed.

Key Skills and Requirements:

Degree in life sciences or a related field.
Strong understanding of global regulations and guidelines (e.g., ICH, FDA, EMA) related to clinical trials and post-approval processes.
Experience in managing escalations, CAPA advisement, and inspection readiness.
Proficiency in using electronic quality management systems and MS Office tools.
Ability to work collaboratively in a cross-functional, global matrix environment.
Effective communication skills for engaging with internal and external stakeholders.
Fluent in written and spoken English.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

̽��ϼ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽��ϼ� is acting as an Employment Agency in relation to this vacancy.

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