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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:
Preferred Qualifications:
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.