Talent.com
Associate Director, Document Control Processes -Global Topic Owner -
Associate Director, Document Control Processes -Global Topic Owner -Kite Pharma • Frederick, MD, US
Associate Director, Document Control Processes -Global Topic Owner -

Associate Director, Document Control Processes -Global Topic Owner -

Kite Pharma • Frederick, MD, US
30+ days ago
Job type
  • Full-time
Job description

Global Document Control Manager

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.

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 :

Program Development and Implementation :

  • 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
  • Create a job alert for this search

    Document Control • Frederick, MD, US

    Related jobs
    ICAM Technical SME Associate Director

    ICAM Technical SME Associate Director

    Guidehouse • Tysons Corner, Virginia, USA
    Full-time
    Ability to Obtain Public Trust.Our Cybersecurity consultants are a team of business integrators with extensive consulting and industry experience who help our clients solve their complex business i...Show more
    Last updated: 9 days ago • Promoted
    Associate Director, FP&A (Preferred Candidate Location-MD, PA, NJ- must live on East Coast)

    Associate Director, FP&A (Preferred Candidate Location-MD, PA, NJ- must live on East Coast)

    Altimmune • Gaithersburg, MD, USA
    Full-time
    Quick Apply
    Reporting to the Vice President of Finance, the Associate Director, FP&A, is responsible for supporting corporate, functional, and program-level budgeting, financial reporting, financial analys...Show more
    Last updated: 30+ days ago
    Director 2 Technology & Innovation

    Director 2 Technology & Innovation

    Northrop Grumman • Falls Church, VA, US
    Full-time
    Director 2 Technology & Innovation Leader.At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and f...Show more
    Last updated: 2 days ago • Promoted
    Associate Director Oncology Outcomes Research-Gaithersburg, MD

    Associate Director Oncology Outcomes Research-Gaithersburg, MD

    AstraZeneca • Gaithersburg, Maryland, USA
    Full-time
    At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious thinking and innovation ultimately providing employees with the opportunity to work...Show more
    Last updated: 25 days ago • Promoted
    Director 2 Technology & Innovation

    Director 2 Technology & Innovation

    Virginia Staffing • Falls Church, VA, US
    Full-time
    Director 2 Technology & Innovation Leader.At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and f...Show more
    Last updated: 19 hours ago • Promoted • New!
    Associate Director, Technology Services

    Associate Director, Technology Services

    Cooperative Education • Fairfax, VA, United States
    Full-time
    Auxiliary Services and Operations.Not eligible for visa sponsorship.The purpose of Auxiliary and Business Services (ABS) is to support the overall mission of the University and to improve quality o...Show more
    Last updated: 30+ days ago • Promoted
    Tax Director, North America

    Tax Director, North America

    Parsons Corporation • Centreville, VA, United States
    Full-time
    In a world of possibilities, pursue one with endless opportunities.At Parsons, you can imagine a career where you thrive, work with exceptional people, and be yourself. Guided by our leadership visi...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director - Finance Transformation, M&A Support (PE / Growth)

    Associate Director - Finance Transformation, M&A Support (PE / Growth)

    Cross Country Consulting • McLean, VA, United States
    Full-time
    From the beginning, our goal was to establish an advisory firm that stands apart from the rest – one that is grounded in our Core Values and dedicated to creating a positive experience not just for...Show more
    Last updated: 13 days ago • Promoted
    Accounting Associate Expense Reports (Remote - DC / MD / VA)

    Accounting Associate Expense Reports (Remote - DC / MD / VA)

    Remote Staffing • Fairfax, VA, US
    Remote
    Full-time
    GovCIO Expense Report Associate.GovCIO is currently hiring for an expense report associate to process high volume expense reports in Deltek / Costpoint. This position will be located in Fairfax, Virgi...Show more
    Last updated: 14 days ago • Promoted
    Data Integration Program Director

    Data Integration Program Director

    Capital One National Association • McLean, VA, United States
    Full-time
    Data Integration Program Director.At Capital One we’re building a leading technology company.Founded by Chairman and Chief Executive Officer Richard Fairbank, Capital One helps our customers succee...Show more
    Last updated: 28 days ago • Promoted
    Director, Software Engineering (Individual Contributor)

    Director, Software Engineering (Individual Contributor)

    ATPCO • Herndon, Virginia, USA
    Full-time
    Director Software Engineering (Individual Contributor) for Airline Tariff Publishing Company (ATPCO) may work remotely and report to our Herndon VA HQ loc. Design & architect next-gen tech solut...Show more
    Last updated: 10 days ago • Promoted
    Associate Director - Finance Transformation, M&A Support (PE / Growth)

    Associate Director - Finance Transformation, M&A Support (PE / Growth)

    CrossCountry Consulting • McLean, VA, United States
    Full-time
    Associate Director - Finance Transformation, M&A Support (PE / Growth).Join CrossCountry Consulting as an Associate Director to lead M&A integration projects for middle market private equity clients....Show more
    Last updated: 15 days ago • Promoted
    Assoc Director, Quality Control

    Assoc Director, Quality Control

    Kite Pharma • Frederick, Maryland, USA
    Full-time
    Were 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. Weve made incredible scientific...Show more
    Last updated: 30+ days ago • Promoted
    Senior Associate, Product Management Enterprise Document Management Platform

    Senior Associate, Product Management Enterprise Document Management Platform

    Capital One • McLean, Maryland, USA
    Full-time +1
    Senior Associate Product Management - Enterprise Document Management Platform.Product Management at Capital One is a booming vibrant craft that requires reimagining the status quo finding value cre...Show more
    Last updated: 23 days ago • Promoted
    Associate DirectorDirector of Biostatistics

    Associate DirectorDirector of Biostatistics

    Penfield Search Partners • Gaithersburg, Maryland, USA
    Temporary
    Contact : Neisha Camacho / Terra Parsons -.On-Site / hybrid - Candidates must be local to Gaithersburg MD.Reporting to the Vice President of Biostatistics and Data Management this individual will provid...Show more
    Last updated: 21 days ago • Promoted
    Document Reviewer

    Document Reviewer

    KLDiscovery • McLean, VA, United States
    Full-time
    KLDiscovery, one of the largest national eDiscovery providers, is currently seeking attorneys who are actively licensed in any U. We have an ongoing need for Document Reviewers.Document Reviewers wi...Show more
    Last updated: 30+ days ago • Promoted
    Senior Associate, Product Management- Acquisitions

    Senior Associate, Product Management- Acquisitions

    USA Jobs • Falls Church, VA, US
    Full-time +1
    Senior Associate, Product Management- Acquisitions.Product Management at Capital One is a booming, vibrant craft that requires reimagining the status quo, finding value creation opportunities, and ...Show more
    Last updated: 19 hours ago • Promoted • New!
    Associate Director, Technology Services

    Associate Director, Technology Services

    George Mason University • Fairfax, VA, United States
    Full-time
    Associate Director, Technology Services .Auxiliary Services and Operations.Not eligible for visa sponsorship.The purpose of Auxiliary and Business Services (ABS) is to support the overall mission o...Show more
    Last updated: 30+ days ago • Promoted