Senior Quality Agreements Compliance Manager

Highly Competitive Salary
  1. Contract
  2. Senior/Director & VP
  3. United States
Foster City, California
Posting date: 21 Nov 2018
QA.SH.20622_1542831764

At ProClinical, we are seeking an experienced individual to fill the role of Senior Quality Agreements Compliance Manager, based in Foster City, CA.

Responsibilities

  • Assign, monitor and review progress and accuracy of work for an individual, a group of employees, or a project.
  • Follow up on questions from assigned departments.
  • Maintain standard of quality for compliance department operations.
  • Assist in regulatory agency inspections.
  • Interact and influences peers to ensure successful project completion.
  • Maintain current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.
  • Provide guidance on interpretation and application of specified QA compliance regulations.
  • Assist in the evaluation and implementation of relevant SOPs and systems.

Skills And Qualifications

  • BA/BS and 8+ years of relevant pharmaceutical industry experience OR MS and 6+ years of experience. Knowledge of/experience with supplier negotiations strongly preferred.
  • Quality agreement expertise with experience in FDA regulations and GMP.
  • Experience editing agreements based on QA-specific guidelines, as well as template-building and utilization of templates for agreements.
  • Quality agreement expertise, both domestic and international GMP regulations and/or extensive contracting experience in the pharma/biopharma industries.
  • In-depth experience with electronic document control management or electronic contract life-cycle management systems.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sherron Howard at (+1) 2674358600 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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