Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
As a Quality Partner within Early Clinical Development (ECD) Quality, you will champion a proactive, risk-based quality culture that enables innovative science to move safely and efficiently to patients. You will serve as the primary Good Clinical Practice (GCP) quality advisor and strategic partner to early-stage clinical trial study teams and external partners. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- You bring a Bachelor’s degree in a life science, healthcare, or related discipline (advanced degree such as MS, PhD, JD, or MD welcomed)
- You hold comprehensive working knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory frameworks and how to apply them to clinical trial conduct
- You bring proven analytical and problem-solving skills, with a track record of identifying compliance risks, facilitating root cause analyses, and architecting practical CAPA solutions
- You excel at cross-functional collaboration and stakeholder management, with the ability to translate regulatory requirements into clear, actionable guidance while managing priorities independently
More about this role
We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society.
As a Quality Partner within Early Clinical Development (ECD) Quality, you will champion a proactive, risk-based quality culture that enables innovative science to move safely and efficiently to patients. You will serve as the primary Good Clinical Practice (GCP) quality advisor and strategic partner to early-stage clinical trial study teams and external partners. In this role, you will embed quality by design across cutting-edge Early Development clinical programs, resolving complex compliance challenges before they impact study timelines or regulatory integrity.
- Develop strategic partnerships with cross-functional teams in Early Clinical Development (ECD) and external vendor partners to advance compliance solutions and enable transparent issue resolution.
- Provide expert GCP quality guidance, direction, and proactive risk-mitigation strategies to support early clinical trial conduct.
- Support...
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