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Associate Director, Document Control Processes -Global Topic Owner -

Associate Director, Document Control Processes -Global Topic Owner -

Gilead SciencesSanta Monica, CA, US
6 days ago
Job type
  • Full-time
Job description

Join Kite Pharma

We're here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

The role is responsible for establishing, implementing, and overseeing the global document control program. This role ensures that all company documents are managed according to relevant regulations, standards, and internal policies. The role will lead the development and continuous improvement of document control processes, systems, and training to maintain document integrity, accuracy, and accessibility across the organization.

Responsibilities :

  • Develop and implement the strategy for Document Control to drive sustained compliance of CGMP / GDP activities.
  • Develop and implement a comprehensive global document control program, including policies, procedures, and systems.
  • Own the technical content and sustainability of the Document Control topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents.
  • Establish and maintain a framework for document creation, review, approval, revision, storage, and obsolescence.
  • 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.

Governance and Strategic Direction :

  • Provide strategic direction and oversight for the Global Document Control 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 document management.
  • Ensure alignment with applicable regulations (e.g., FDA, ISO), internal policies, and business needs.
  • Manage interdependencies within and across QMS Topics.
  • Provide leadership and technical direction for their Topic and associated support systems across a Global network.
  • System Management :

  • Oversee the selection, implementation, and maintenance of electronic document management systems (Veeva).
  • Ensure system meets the needs of the organization and supports efficient document workflows.
  • Manage system access, security, and data integrity.
  • Training and Communication :

  • Develop and deliver training programs on document control policies and procedures.
  • Promote a culture of document quality and compliance across the organization.
  • Communicate document control program updates and changes to stakeholders.
  • Collaboration and Stakeholder Management :

  • Promote a Culture of Quality and Compliance across the network.
  • Communicate and collaborate with stakeholders on Topic updates and changes.
  • Collaborate with cross-functional teams (e.g., Quality, Regulatory, Operations, R&D) across a global network, to ensure document control needs are met.
  • Partner with senior management to align the document control program with business objectives.
  • Manage relationships with external vendors and service providers.
  • Continuous Improvement :

  • Monitor industry trends and best practices in document control.
  • Identify opportunities for process improvement and innovation.
  • Implement changes to enhance the efficiency and effectiveness of the document control program.
  • Basic Qualifications :

  • 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
  • Preferred Qualifications :

  • 10+ years of experience in the pharmaceutical and / or biotechnology industry operating within, or managing, a global document control network.
  • Experience with Veeva eDMS is preferred
  • Excellent communication and influencing skills
  • Proven ability to work and influence across a global network
  • Ability to collaborate and work cross-functionally
  • Creative problem solving approach and solutions based mindset
  • Ability to provide cross-functional leadership
  • The salary range for this position is : $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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    Document Control • Santa Monica, CA, US

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