- Reporting to the Sr. Director of GCP/GLP Quality, the Associate Director, GCP Quality will provide quality and compliance support and across Principia clinical projects. Additionally, the position will be responsible for designing and implementing quality plans to include external GCP audits of clinical services providers, CROs, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures.
- The individual will be a critical team member who supports the risk-based GCP audit programs and compliance oversight. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Abilities and responsibilities:
- Formulates GCP compliance strategy and provide advice for assigned programs or studies<