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Manager Quality Assurance GCP/GXP
As Manager, Clinical Quality Assurance (CQA), your role is to assure a high level of quality in Eisai Global Clinical Research projects, as defined in Federal Regulations, local regulations, GxP, Eisai policies and applicable industry standards. In this role, your specific responsibilities will include the following:
Conducting clinical investigator site audits and GCP document audits and authoring audit reports with minimal supervision.
Ensuring that CQA has the support required to achieve the groups objectives and provides technical insight as needed to ensure progress towards project goals.
Facilitating ongoing quality improvement through communication of audit results and compliance guidance.
Assisting in the management of multiple resources within and across groups to meet project deliverables. This may include assisting with resource allocation to execute Clinical QA initiatives and/or managing contract auditors on an as needed basis.
Understanding the strengths and weaknesses of the team and contributing to plans to get the highest and best use of team members. Assisting the Sr. Manager in providing training for department members.
Conducting internal process/system and external vendor audits and authoring audit reports.
Fully contributes to Clinical QA problem solving. Identifies issues and proposes solutions.
Qualified Candidates will have:
A Bachelors degree in a related discipline.
4-7 years of relevant experience in the pharmaceutical industry including external/CRO, clinical/regulatory and document auditing experience.
In-depth knowledge of US, EU and International regulatory standards and guidelines for the conduct of clinical trials.
Successful candidates will also possess the technical and administrative abilities required to carry out routine audits with minimal supervision or to play a supporting role in more complex audits.
As a representative of the CQA Department, the successful candidate must be able to interact at all levels (internally and externally) while demonstrating diplomacy, professionalism and tact. He/She must also possess the following attributes as it relates to his/her work habits and report writing: attention to detail, thoroughness and analytical skills. Excellent written/verbal communication skills, the ability to independently manage ones time and the ability to multi-task are also required.
An advanced academic degree and ASQ, Auditor, Clinical Trial Associate or Clinical Trial Manager accreditation highly desirable.
Candidates must be able to travel a minimum of 25%.
Contact Jamie@Pharmasearchpartners.com
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Salary: $110000 to $130000 Per Year
Position Type:
Employee
Ref Code: jr002 |
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