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
We are seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team. You will bring diverse thinking and technical experience in various Quality disciplines (e.g., GCP, CSV, device). Note: This role requires strong level GCP knowledge and will be accountable for the quality assurance aspects and leading/supporting inspections of key molecules. CSV and device are preferred but not the main requirement. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree or equivalent in scientific or quality-related field. Advanced degree preferred
- Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements
- Project management experience with proven leadership, mentoring and coaching, Demonstrated ability to effectively organize and execute tasks
- High degree of experience, competency, and proven track record leading multiple complex audit types in multiple GCP areas
- Device / CSV experience
- Strong digital and data literacy
More about this role
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech / Roche!
In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivaled transparency with health authorities, patients, and society. Our work provides leadership, know-how, and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and global regulated processes.
This role supports the Roche/Genentech Organization by developing and delivering Quality Assurance strategies, audits, and conclusions for post approval products, affiliates and processes, based on a risk-based approach. Quality Assurance strategies are based on the Critical to Quality framework, encompassing Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Medical Device, and Computer Systems (CS) requirements.
We are seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team. You will...
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