Manager, Clinical QA

Discover a rewarding opportunity in the life sciences sector focused on advancing therapies that address serious health conditions. You will join a forward-thinking organization dedicated to innovative research in cortisol modulation, with an impact spanning endocrinology, oncology, metabolism, and neurology. As part of this journey, you will have the chance to work with cutting-edge clinical quality systems supporting groundbreaking clinical trials—making a real difference in patients’ lives.

Our client is a company pioneering the development of molecules that regulate cortisol activity at the glucocorticoid receptor. They have a proven track record with multiple FDA-approved treatments and a robust pipeline of ongoing studies. This organization values scientific excellence, regulatory compliance, and continuous improvement, providing a dynamic environment where your expertise can truly thrive.

In this role, you will play a key part in ensuring the success of clinical studies by overseeing compliance activities and quality assurance processes. Your work will support the integrity of clinical research and the organization’s reputation for scientific rigor and regulatory excellence. You will collaborate closely with clinical teams, internal departments, and external inspectors, helping to maintain the highest standards of quality and compliance.

Key responsibilities include:

• Lead and manage GCP audits, including site, vendor, and internal audits, ensuring compliance with industry standards.
• Act as a QA representative supporting clinical study teams with compliance advice and review of study documentation.
• Manage study-specific audit plans using a risk-based approach.
• Oversee the approval of investigational product temperature excursions, ensuring timely release or rejection.
• Drive continuous improvement of quality management systems and SOPs for GCP compliance.
• Support inspection readiness activities and facilitate regulatory agency inspections.
• Lead investigations into non-compliance events, implementing corrective actions.
• Analyze quality metrics to identify trends and inform process improvements.
• Stay current with regulatory requirements and industry standards.
• Mentor junior QA team members and support cross-training initiatives.

Ideal candidates will have:

• A BA/BS degree in a relevant field or equivalent experience.
• 6+ years of clinical research experience, with a strong understanding of quality systems supporting GCP activities.
• Experience developing and enhancing GCP processes and training.
• Proficiency with advanced Microsoft Office tools.
• Exceptional organizational, communication, and problem-solving skills.

This role offers a base salary between $154,000 and an undisclosed upper limit, depending on experience. It requires an on-site presence typically three days per week, supporting a flexible hybrid work environment.

Apply now to be part of a growing organization shaping the future of clinical research in the life sciences.

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