GCP Operational Quality Associate Director
Core
Provides biomarker quality leadership and oversight across GxP-related research, development, and clinical trials, ensuring compliance and operational excellence for future IVD commercialization.
Role type
Senior IC quality operations leader (biomarkers/GxP)
Builds
Quality oversight systems, compliance frameworks, and vendor audit strategies for preclinical and clinical biomarker programs.
Domain
Biotechnology / Clinical Research / Regulatory Quality (GxP, GLP, GCP)
Required skills
GxP/GLP/GCP compliance, data integrity (ALCOA), regulatory document review (IND/IDE/TMF), vendor quality audit, quality metrics & dashboards, risk identification, cross-functional collaboration
Preferred skills
CLIA regulations (42 CFR Part 493), ISO15189:2022, in-vivo/in-vitro experimental design, strategic cross-functional initiatives, inspection readiness
Technologies
None explicitly stated
Responsibilities
Partner with quality/compliance on preclinical and clinical activities; review regulatory documents (BBs, INDs, IDEs, TMFs); develop audit scope for vendor audits; contribute to strategic compliance initiatives; identify and resolve compliance issues; conduct inspection readiness assessments; design quality metrics; communicate quality insights to stakeholders; support non-GxP research QA reviews.
Seniority
Senior, hands-on IC
