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Career Opportunities
Manager/Senior Manager, Clinical Quality Assurance | Quality
Eisai Inc. -- Woodcliff Lake, New Jersey | | | Job Description- The Manager/Senior Manager of Clinical Quality Assurance defines and implements procedures to assure that all activities subject to regulatory review and conducted within Eisai, Inc. comply with internal, International and U.S. domestic standards and guidelines. This position will report directly to the Vice President, Quality Operations. Key responsibilities include:
- Partnering with Medical Affairs and Medical Services to ensure CGCP implementation
- Developing inspection/audit plans and conducting audits to assess compliance with US and International regulatory rules and guidelines, and with internal standards and operating procedures
- Contracting and oversight with external vendors to conduct audits; reviews and assesses compliance status of contracted services
- Participation in Vendor Selection program
- Reviewing Standard Operating Procedures to assess consistency and compliance with regulatory and internal standards, and to determine and ensure appropriate follow through across organizational boundaries
- Reviews safety and pharmacovigilance practices for compliance
- Serves as primary contact for external audits of Eisai New Jersey facility
- Participates in corporate (ECL) compliance initiatives to develop and align local quality assurance policies with international Eisai quality policy and procedures
| Qualifications- Bachelors' degree in a scientific discipline and at least 5 years prior experience in pharmaceutical industry, in the area of Clinical Quality Assurance. Prior responsibility for compliance audits, development of operating procedures and guidelines.
- Eisai is an Equal Opportunity Employer
Date Posted6/20/2006 |
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