Covance is seeking candidates for Manager Quality Assurance & Compliance. The Manager Quality Assurance & Compliance can be remotely located anywhere within the United States.
- Manage and support Clinical QA needs of assigned clients and their respective clinical trial programs.
- Plan, manage and conduct monthly QA to QA meetings with assigned client QA contacts.
- Develop, manage and maintain Quality Agreements for assigned clients.
- Provide GCP support and consultation to internal Covance project teams.
- Attend study team meetings for Clinical QA input as needed.
- Provide Inspection Readiness support to Covance teams and respective clients.
- Provide Inspection Management support for Covance and client inspections including overseeing development of inspection responses, QC review of responses, client communications, preparing daily summaries, managing inspection mailbox & tracker, and Inspection follow-up.
- Support the Client Interactions group for client audits including onsite client audit support when necessary.
- Participation in Joint Operating Committee meetings.
- University or College Degree (BA/BS, life science preferred) or equivalent experience.
- Must have at least 5 years direct GCP QA experience in a CRO or sponsor quality organization.
- Must have strong working knowledge and application of GCP, ICH GCP and local regulations.
- Must have strong interpersonal and communication skills and the ability to effectively work with QA representatives of Covance clients who maybe be of equal or higher level.
- Must have working knowledge of CAPA and CAPA processes.
- Must have ability to travel up to 10%.
- Prior experience in supporting client audits and regulatory inspections.
Posting ID: 584170873Posted: 2020-12-01