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Senior Manager, Quality Assurance- Global Product Distribution & Affiliates

United States - California - La VerneQualityRegular
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Job Description

Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to a US and Global product distribution operation.

  • Maintains routine programs and processes to ensure high quality products and compliance with FDA current Good Distribution Practice (GDP) and National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements.

  • Supports Global and Regional QA teams as well as working cross-functionally with Global Logistics, Supply Chain, Warehouse, Customer Service personnel as well as facilities, EHS and validation colleagues in all aspects of product distribution.

  • Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues.

  • Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met.

  • Reviews shipping records, environmental monitoring and associated data relating to product distribution activities.

  • Hosts NAPB external audits and interacts closely with external regulators/stakeholders.

  • Co-hosts/supports external FDA audits and internal audit programs.

  • Participates in the development & delivery of training programs regarding relevant to US and Global product Distribution.

  • Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Operations.

  • Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards.

  • Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required.

Knowledge, Experience & Behaviors:

  • Experience in US market and international product distribution, to include supporting/hosting FDA and State Pharmacy Board inspections.

  • Demonstrates proficiency in Good Distribution Practices (GDP), Verified-Accredited Wholesale Distributors (VAWD) and Drug Supply Chain Security Act (DSCSA) requirements.

  • Demonstrates working knowledge with good proficiency in Microsoft Office applications.

  • Experience in providing QA oversight of contracted 3PL activities.

  • Resilient profile with the ability to deliver in a challenging environment.

  • Ability to engage and manage multiple stakeholders to achieve the objective.

  • Organised with systematic approach to prioritisation.

  • Positive attitude

  • Motivated to learn new skills and embrace new experiences.


Gilead Core Values:
• Integrity (always doing the right thing)
• Teamwork (collaborating in good faith)
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity)