Manager/Senior Manager of Clinical QA - Pharmaceutical

Job Description:
Well known Pharmaceutical company is seeking a Manager of Clinical Quality Assurance for a direct hire opportunity. This position defines & implements procedures to assure that all activities subject to regulatory review comply with all standards and guidelines. This position will report directly to the Vice President, Quality Operations. Key responsibilities for this position 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 & ensure appropriate follow thorough across organizational boundaries. Reviews safety and pharmacovigilance practices for compliance. serves as primary contact for external audits of facility. Participates in corporate compliance initiatives to develop and align local quality assurance policies with international company quality policy and procedures. This is an excellent opportunity with good benefits. Don't miss this! Apply today! You can view all of our jobs online at http://www.act1tech.com/?sc=11

Job Experience:
call for details, Bachelor's degree in a scientific discipline and at least 5 years of experience in pharmaceutical industry, in the area of Clinical Quality Assurance. Prior responsibility for compliance audits, development of operating procedures & gui

Searchable Keywords: call for details, Bachelor's degree in a scientific discipline and at least 5 years of experience in pharmaceutical industry, in the area of Clinical Quality Assurance. Prior responsibility for compliance audits, development of operating procedures & gui / gj-mo