Director Compliance – Process Documentation

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-29795
Director Process Documentation responsible for providing strategic leadership to ensure excellence in controlled documents management for R&D. The role is a global role and reports to the Executive Director, Global R&D Quality.
Responsible for:
Setting the strategy, direction and methods for robust controlled documents management for R&D document management. Leading complex cross-functional documentation change initiatives across R&D. Facilitating cross-functional collaborations to initiate and sustain an integrated approach for process documentation. Providing authoritative guidance to R&D functions to ensure quality documentation principles are adhered to while achieving business objectives. Identifying and addressing R&D controlled documentation issues and provide resolutions to the issues. Develop and manage staff. The ideal candidate is considered an Electronic Data Management (EDM) Quality expert specifically for R&D.
Significant experience in Quality Management, Document Management, Compliance, or other relevant area of pharmaceutical/biotech industry
Team management and development
Document and process management expert
Change management expertise
In depth knowledge of global regulations impacting R&D activities
Quality Management System oversight & implementation
Document Management
Project Management
Basic Qualifications
Doctorate degree and 4 years of Electronic Data Management (EDM) experience
Master's degree and 7 years of Electronic Data Management (EDM) years
Bachelor's degree and 9 years of Electronic Data Management (EDM) experience
Preferred Qualifications
Master's degree or other advanced degree
Project Management/Leadership experience
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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