We are seeking a skilled Clinical Quality Professinal to support study team compliance with national and international regulatory standards and guidelines for cell therapy products. This role offers the opportunity to contribute to a growing biotech focused on innovative therapies for oncology and autoimmune diseases.
Key Responsibilities:
Act as a Clinical Quality lead by ensuring study teams adhere to GCP and regulatory requirements.
Develop and execute audit plans and strategies for ongoing clinical trials.
Perform initial and ongoing audits of clinical vendors.
Coordinate, plan, and conduct internal system audits and external site/vendor audits in accordance with GCP guidelines.
Report audit findings to management, provide recommendations, and verify corrective actions.
Support the development and maintenance of clinical SOPs, work instructions, forms, and templates.
Develop and deliver GCP and inspection readiness training for staff.
Assist in preparation for and execution of regulatory inspections.
Provide quality and regulatory compliance guidance to clinical teams.
Qualifications & Experience:
Bachelor's degree with 8+ years of GCP experience in a pharmaceutical or biologics environment. Experience in Clinical Quality in related industries (e.g., medical device or diagnostics) will be considered. More experienced candidates may be considered at a senior level.
Experience implementing and integrating clinical quality systems in a regulated biotechnology setting.
Strong knowledge of applicable GCP regulations and industry guidance.
Proven ability to assess risk, prioritize effectively, and meet project deadlines in a fast-paced environment.
Excellent communication, presentation, and relationship-building skills.
Ability to travel up to 20% as needed.
This role offers a clear path for career progression within a company committed to innovation and patient impact. If you're interested in learning more, let's connect!