Clinical Quality Assurance Sr. Manager/Assoc. Director
Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patient’s best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences. Through a series of strategic alliances, Infinity is in a position to independently fund the development and commercialization of its drug candidates.
The Clinical Quality Assurance will be responsible for leading the company’s clinical quality assurance function. The incumbent will oversee external and internal (Clinical Operations, Data Management and Pharmacovigilance) quality GCP programs in accordance with organizational and industry quality standards and regulations. This individual will work to implement new and improve upon current Infinity quality systems and workflows.
- Provide support and proactive, strategic planning for QA oversight of clinical development activities.
- Liaison between Quality and Clinical Operations, Data Management, Pharmacogivilance and general Medical functions.
- Ensure operations in clinical development are compliant with FDA, ICH EMA and industry standards
- Participating in and/or facilitating process-improvement efforts within Clinical Development
- Review Clinical Study Reports for a broad range of clinical programs
- Mentor other Quality Assurance team members to build divisional bench strength and knowledge regarding Clinical Operations and applicable regulations
- Provide GCP training to both Infinity personnel and clinical sites.
- Review of clinical and data operational plans
- Liaison with Auditor on internal auditing program to ensure compliance of operations with company and quality group’s policies and procedures.
- 8-10+ years of industry experience; at least 5 years of GCP/clinical quality assurance experience
- Strong understanding of clinical operations, data management and pharmacovigilance operations
- BS required, advanced degree a plus.
- Title will be commensurate with education and experience of the selected candidate.
To apply, please visit our website at http://www.infi.com/careers-opportunities.asp