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Job Overview:The Manager, Quality Assurance can be remotely (home based) located any where 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 as appropriate to the QA relationship with the client.
Develop, manage and maintain Quality Agreements for assigned clients.
Provide QA support to TAs as assigned, working across a variety of studies within the TA, including discussion of quality matters and provision of required metrics.
Provide GCP support and consultation to internal Covance project teams.
Attend study team meetings for Clinical QA input as designated.
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.
Assist with Inspection follow-up, including review of inspection report responses and lessons learned activities.
Support the Client Interactions group for client audits including onsite client audit support when necessary.
Assist with review of responses to client audit findings.
Assist the development of CAPA Plans as well as review CAPA plans generated from quality issues, audits, inspections etc.
Participation in other client meetings as required (such as bid defenses, QA face to face meetings, Joint Operating Committee meetings).
Provide local regulatory agency expertise as required based upon knowledge and experience.
Education/Qualifications:
University or College Degree (BA/BS, life science preferred) or equivalent experience.
Experience:
Must have at least 3 - 5 years direct GCP QA experience in a CRO or sponsor quality organization.
Must have strong working knowledge and application of GCP, ICH GCP, regional 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.
Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.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.
