Associate Director, Clinical Quality Assurance

Associate Director, Clinical Quality Assurance

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

The Associate Director, Clinical Quality Assurance provides expert guidance on Good Clinical Practice (GCP) compliance and quality oversight for clinical studies. This role supports the development and maintenance of the Quality Management System, ensures proper documentation and resolution of quality events, and leads process improvement initiatives. Responsibilities include reviewing clinical trial documents, planning and / or conducting internal and external audits, and supporting regulatory inspections. The position is critical for driving continuous improvement and maintaining adherence to industry standards and regulatory requirements.

Responsibilities include :

• Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
• Work closely with clinical study teams to ensure / coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
• Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
• Lead small-scale process improvement projects, as needed
• Provide clinical quality assurance SME review of clinical protocols, and other clinical trial-related documents
• Plan, conduct, and / or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
• Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
• Provide support for quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.
• Other duties as assigned or required

This is a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are includes :

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Financial Benefits :

Health & Wellbeing :

Skill Development & Career Paths :

Salary : $166,993.75 - $197,070.25 USD