Sr. Manager, QA Compliance - Global Quality Agreements : 18-05250

Foster City, CA 94404

Posted: 11/26/2018 Job Category: Quality Assurance and Testing Job Number: 11611216
Akraya is looking for a Manager, QA Compliance - Global Quality Agreements   for one of our clients. If the job description below is a fit, please apply directly or call Makarand Patil at 703-595-4443. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
 
Primary Skills:  QA compliance, GMP, document control, agreement/contract
Duration: 12 Months
Contract Type: W2 only


Description:
 
The Manager, QA Compliance will report to the Associate Director, QA Compliance – Global Quality Agreements within the Supplier Management and Audits department.
 
Responsibilities:
  • Responsible for assisting with the implementation of the Global Quality Agreement Program initiatives (governance, oversight, processes and services) by collaborating cross-functionally and geographically with key stakeholders
  • Responsible for managing the Quality (Technical) Agreement (QAG) life-cycle process (processing requests, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, conducting periodic reviews, and retiring, creating training materials) for Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), GMP Materials Suppliers, GMP Services Providers .
  • Assist in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of QAGs and compliance monitoring thereof
  • Provides global QAG Program systems and processes support to SMA/QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies
 
Specific Education & Experience Requirements:
  • 8+ years of relevant experience in the pharmaceutical industry and a BS or BA, 6+ years of relevant experience and a MS 
  • Demonstrates expertise with quality agreements for both domestic and international GMP regulations and/or extensive contracting (contract drafting/negotiating) experience in the pharmaceutical/biopharmaceutical industry
  • Demonstrates excellent technical/business/legal writing skills; must have strong document or contract management skills (word processing/formatting)
  • Excellent working knowledge of computer systems/applications; i.E. Microsoft Word, Excel, Pivot tables, Visio, Gantt Charts, and PowerPoint
  • In-depth experience with electronic document control management or electronic contract life-cycle management systems (e.G.: Documentum, Veeva Quality Docs, Apttus, Ariba, or other electronic document control/contract life-cycle management systems)
 
    Please apply directly with your update resume or call Makarand Patil at 703-595-4443
 
About Akraya
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.

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