Senior Manager, Clinical Quality Assurance

Responsibilities:
- Develop/manage study audit plans using a risk-based approach.
- Lead/manage Good Clinical Practice (GCP) audits (investigator sites, Trial Master File (TMF), and applicable study documents including CSRs).
- Support clinical service provider and internal process audits.
- Assess changes to qualified service provider services and impacts to ongoing studies.
- Serve as CQA Lead representative and provide compliance support/oversight through the study lifecycle.
- Support risk management: identify CtQ factors, implement risk-proportionate activities, and monitor risks to CtQs.
- Review clinical study documents/plans and provide CQA compliance review/approval of clinical development SOPs.
- Manage/support GCP inspection readiness in line with study milestones.
- Support regulatory inspections (sponsor, investigator site, and service provider).
- Lead critical investigations to ensure regulatory reporting compliance.
- Support/review/approve clinical non-compliance records (deviations and CAPA).
- Maintain knowledge of GCP-related regulations/standards.
- Cross-train/mentor junior QA team members; some travel required.

Preferred Skills, Qualifications and Technical Proficiencies:
- Thorough understanding of quality systems supporting GCP.
- Experience developing GCP processes.
- Experience leading complex quality investigations, root cause analysis, and CAPA.

Preferred Education and Experience:
- BS/BA in science or related field (or equivalent experience).
- 8+ years clinical research experience; 2+ years CQA experience preferred.

Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.