Associate Director, Early Development Quality Lead, R&D QA
Core
Strategic quality oversight of internal and external laboratory activities supporting nonclinical studies (GLP/non-GLP), IND enabling work, and biomarker utilization within development programs.
Role type
Senior IC quality lead (nonclinical/early development)
Builds
Quality governance frameworks, audit programs, and risk mitigation strategies for outsourced CRO/vendor activities
Domain
Biopharmaceutical R&D / Nonclinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
Strategic quality oversight, vendor/CRO governance, risk assessment and audit strategy, CAPA management, regulatory compliance (GCP/GLP/ICH/OECD), process improvement
Preferred skills
Life sciences education (biology/pharmacy), bioanalytical and toxicology subject matter expertise, Master's degree in science/technology
Technologies
QMS (Quality Management Systems), GCP/GLP/ICH/OECD regulatory frameworks
Responsibilities
Set strategic quality direction for internal and outsourced nonclinical lab activities; Establish and maintain quality oversight of external laboratories via governance frameworks; Collaborate with nonclinical/clinical teams on external lab selection and contracting; Ensure biomarker development complies with regulatory standards; Lead risk assessment and audit strategy for external labs; Manage quality issues and CAPA oversight for outsourced activities; Serve as escalation point for vendor quality issues; Drive process improvement within the QMS; Partner with Legal/Procurement for contractual oversight language
Seniority
Senior, hands-on IC with strategic oversight
