Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing QA team to be based in St. Louis, MO or San Diego, CA. This candidate will be responsible for establishing and maintaining Wugen Clinical Quality Assurance Systems and giving Quality guidance and support to both internal customers and external service providers.
- Perform Quality Assurance review and approval of Clinical documents including protocols, Informed Consents, Investigator Brochures, Trial Master Files, clinical labels.
- Provide input to clinical functions to ensure that clinical trial activities are conducted by CROs in compliance with GCP regulations and internal requirements.
- Develop Quality Agreements and Quality metrics and provide Quality Assurance support and guidance to contract service providers and clinicians.
- Manage and maintain the vendor qualification program and GCP contract service provider audits.
- Lead/participate in GCP audits for investigator sites and vendors, domestic and international.
- Collaborate with functional teams to provide Quality guidance and assistance with development of documents and processes using risk management principles.
- Develop Quality Systems to support Wugen sponsored Clinical Trials including complaints, management of records and data, and tracking of protocol deviations and their resolution.
- Champion the integration of core Clinical Quality Systems for Wugen including documentation, investigations, CAPA, and change control.
- Apply critical thinking and problem-solving skills to identify potential compliance issues and offer solutions.
- Manage the GCP training program and provide training as required including the annual GCP training.
- Participate in preparations for regulatory inspections as the Clinical QA Study Lead.
- Periodically travel on assignment to investigator sites and vendors
- BS/MS degree in science with 8+ years of pharmaceutical work experience.
- Applied knowledge of Quality/Compliance and GCP, GLP, and/or GMP requirements.
- Broad knowledge/experience in Clinical QA, with biologics/cell therapy experience a plus.
- Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced, collaborative work environment.
- Detail oriented with strong organizational and communication skills.
- Strong knowledge in standard software including Word, Excel, and PowerPoint.