Job Description

Manager/Senior Manager Clinical Quality Assurance

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!

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