Gilead Sciences

Associate Director, Global Quality Systems – Change Management

Gilead Sciences

full-time

Posted on:

Location Type: Hybrid

Location: Santa Monica • California • Maryland • United States

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Salary

💰 $165,495 - $214,170 per year

Job Level

Lead

About the role

  • Develop and implement the strategy for Change Management to drive sustained compliance of cGMP activities
  • Develop and implement a comprehensive global Change Management program, including policies, procedures, and systems
  • Own the technical content and sustainability of the Change Management topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents
  • Establish and maintain a framework for change creation, review, approval, revision, and governance
  • Ensure the program aligns with relevant regulations (e.g., FDA, ISO), industry standards, and business needs
  • Lead continuous improvement efforts and remaining current with regulatory changes and industry best practices
  • Provide strategic direction and oversight for the Global Change Management program
  • Establish and monitor key performance indicators (KPIs) to assess program effectiveness
  • Conduct regular audits and assessments to ensure compliance with document control requirements
  • Identify and mitigate risks associated with change management
  • Manage interdependencies within and across QMS Topics
  • Provide leadership and technical direction for their Topic and associated support systems across a Global network
  • Oversee the selection, implementation, and maintenance of Change Management systems (Veeva)
  • Develop and deliver training programs on supporting Change Management policies and procedures
  • Promote a culture of quality and compliance across the organization

Requirements

  • PhD with 2+ years of related experience in a biologics or pharma organization OR MS/MA with 8+ years of related experience in a biologics or pharma organization OR BS/BA with 10+ years of related experience in a biologics or pharma organization
  • High School diploma with 14+ years of related experience in a biologics or pharma organization
  • 6+ years of experience in the pharmaceutical and/or biotechnology industry providing change management and direct strategic oversight of change management for a Quality or Manufacturing oriented group
  • Experience with Veeva eDMS is preferred
Benefits
  • Health insurance
  • Paid time off
  • Discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Benefits package
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Change ManagementcGMPPolicy DevelopmentStandard Operating ProceduresKey Performance IndicatorsRisk ManagementContinuous ImprovementAuditingTraining DevelopmentDocument Control
Soft Skills
LeadershipStrategic DirectionCommunicationOversightCollaborationProblem SolvingOrganizational SkillsInterpersonal SkillsAdaptabilityCultural Promotion
Certifications
PhDMS/MABS/BA