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Senior Manager, Global Compliance

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: March 7, 2023

Job Description:

Job DescriptionWe are seeking a highly motivated individual to join us as a Senior Manager of Compliance in the Corporate Quality and Compliance department. In this role, you will participate in programs to improve GMP compliance and support the Senior Director along with site management in providing compliance guidance into our global commercialization efforts and serve as a partner to external CMOs and affiliates.Responsibilities (include but are not limited to):

  • Serve as the compliance lead for input into commercialization strategy and external partners (i.e., Gilead Affiliates, CMOs).
  • Provide compliance expertise and support for the maintenance and continual development (or modification) of Kite's compliance program; include and implement all applicable regulatory and company requirements. Author and own global policies to implement requirements across Tech Ops
  • Provide support for all quality-related issues.
  • Provides training and competency to our affiliates on compliance matters.
  • Create and sustain a culture that is based on continuous improvement, with ownership of applicable Quality Policies driving compliance across Tech Ops
  • Assure tracking of key performance metrics and participate in periodic reviews to ensure suitability and effectiveness of the compliance program.
  • Work to create centralized library of compliance interpretations for all geographies.
  • Assure communication of compliance concerns, regulatory agency expectations and industry trends as part of on-going education and training for GMP compliance.
  • Act as internal compliance consultant and/or provide other resources with expertise.
  • Ability to travel up to 30%.
  • Perform other duties as assigned.Basic Qualifications:
    • MS/MA Degree in life sciences or engineering discipline and 6 years of experience in regulated industry, biologics or biotech.
    • BS/BA Degree in life sciences or engineering discipline and 8 years of experience in regulated industry, biologics or biotech.
    • High School Degree in life sciences or engineering discipline and 12 years of experience in regulated industry, biologics or biotech.Preferred Qualifications:
      • 5+ years auditing experience in biologics, international experience
      • American Society for Quality (ASQ), Certified Quality Auditor credentials
      • Working knowledge of the regulatory environment for the manufacture of drugs, biologicals and cellular therapy products.
      • Knowledge of blood/tissue components regulations a plus.
      • Understanding of global cGMP regulations and ISO standards.
      • Excellent analytical and demonstrated problem solving skills.
      • Strong database organization, including development, maintenance, and evaluation (metrics).
      • Excellent verbal and written communication skills.
      • Success working with multifunctional, global teams.#QCQA123#IND123#LI-ML Share: Job Requisition ID R0035139 Full Time/Part Time Full-Time Job Level Manager Click below to return to the Gilead Careers siteClick below to see a list of upcoming eventsClick below to return to the Kite, a Gilead company Careers site

Keywords: Gilead Sciences, Inc., Santa Monica , Senior Manager, Global Compliance, Executive , Santa Monica, California

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