Veterans Jobs

Job Information

Covance Manager Quality Assurance & Compliance in Princeton, New Jersey

Job Overview:

Covance is seeking candidates for Manager Quality Assurance & Compliance. The Manager Quality Assurance & Compliance can be remotely located anywhere within the United States or Canada.

  • 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.

Education/Qualifications:

  • University or College Degree (BA/BS, life science preferred) or equivalent experience.

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.

#LI-REMOTE

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

DirectEmployers