Quality Assurance Leader Early Phase Clinical Research

About The Role

We’re seeking an experienced professional to help lead quality oversight for our early phase clinical research programs. In this role, you’ll ensure site compliance with Good Clinical Practices (GCP), regulatory requirements, and internal SOPs while fostering a culture of quality across cross-functional teams. You’ll oversee an auditor team, develop and maintain quality systems, and partner with clinical operations to proactively identify and mitigate risks to impact drug development and patient outcomes.

The Manager, Quality Assurance is responsible for leading QA staff, resources, and assigned QA activities to ensure effective quality oversight, timely execution, and compliance with applicable internal procedures and external regulatory requirements. The role supports a risk-based quality approach by integrating quality data, audit outcomes, inspection findings, compliance trends, and operational input to guide QA priorities and continuous improvement. The Manager, Quality Assurance also supports inspection readiness, quality issue escalation, staff development, and the effective execution of QA programs within the assigned site, function, or business area.

You'll Do Here Lead and manage QA staff, workload, and priorities to ensure effective execution of QA activities. Provide coaching, performance feedback, and development support to team members. Support hiring, onboarding, training, and ongoing staff development. Promote accountability, consistent QA standards, and professional conduct within the team. Oversee QA programs, including audits, inspections, documentation review, and quality system activities. Ensure QA activities are conducted in compliance with procedures, regulatory requirements, and timelines.

Support audit planning and execution using a risk-based approach. Ensure appropriate follow-up and oversight of audit and inspection findings. Apply risk-based approaches to QA planning, prioritization, and issue escalation. Integrate quality data, audit results, inspection outcomes, and trends to identify risks. Monitor quality indicators and escape significant or recurring issues. Oversee or support quality system activities such as deviations, investigations, root cause analysis, and CAPAs.

Ensure quality issues are properly documented, assessed, and resolved. Support quality initiatives and continuous improvement activities. Recommend improvements to processes, procedures, and QA practices. Support preparation, coordination, and follow-up of sponsor audits and regulatory inspections. Participate in inspections as a QA representative, as applicable. Review audit and inspection responses to ensure accuracy and compliance. Maintain effective relationships with internal stakeholders and external partners.

Ensure QA activities comply with SOPs, policies, and applicable GxP requirements. Maintain awareness of relevant regulatory requirements and industry trends. Support development and maintenance of SOPs and controlled documents. Monitor and report QA metrics, risks, and performance indicators. Provide updates to QA leadership on key issues and initiatives. Communicate effectively with internal teams and external stakeholders. Support escalation of quality issues as needed.

• Bachelor degree or higher, in Chemistry, Biochemistry, Biology
• Minimum of 5 of related experience
• At least 2 years (of the
  5) related supervisory experience
• MS Word, Excel, Outlook and Power Point
• Ability to read and interpret technical documents and industry specific manuals.
• Ability to write advanced reports and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization
• Experience in the pharmaceutical industry.
• Knowledge…