Associate Director, Document Control Processes -Global Topic Owner
Gilead Sciences, Inc., Frederick, Maryland, United States, 21701
Overview
Associate Director, Global Quality Systems - Document Control and Training – United States (Maryland, Frederick; California, Santa Monica). Quality Regular. Job Description
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. Responsibilities
Program Development and Implementation: Develop and implement the strategy for Document Control and Training processes to drive sustained compliance of cGMP/GDP activities. Develop and implement comprehensive Global Document Control and Training processes, including policies, procedures, and systems. Own the technical content and sustainability of the Document Control and Training processes, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents. Establish and maintain a framework for document management and training delivery including creation, review, approval, revision, storage, and obsolescence. Ensure that the processes 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 and Training processes. Establish and monitor key performance indicators (KPIs) to assess process effectiveness. Conduct regular audits and assessments to ensure compliance with internal and external requirements. Identify and mitigate risks associated processes. 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 (Veeva) and learning management systems. Ensure systems meet the needs of the organization and supports efficiency and agility. Manage system access, security, and data integrity. Training and Communication: Develop and deliver training programs on process policies and procedures. Promote a culture of quality and compliance across the organization. Communicate 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 and training needs are met. Partner with senior management to align processes with business objectives. Manage relationships with external vendors and service providers. Monitor industry trends and best practices in document control and training. Identify opportunities for process improvement and innovation. Implement changes to enhance the efficiency and effectiveness of the document control and training processes. Qualifications 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 Benefits and Equal Opportunity
Salary range: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary bonuses, stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For more information, visit the Kite/ Gilead benefits page.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response. Kite is based in Santa Monica, CA. Website: kitepharma.com. Equal Employment Opportunity
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status, or other protected characteristics. Reasonable accommodation requests may be directed to ApplicantAccommodations@gilead.com. Our environment respects individual differences and celebrates the individuals who make up our team.
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Associate Director, Global Quality Systems - Document Control and Training – United States (Maryland, Frederick; California, Santa Monica). Quality Regular. Job Description
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. Responsibilities
Program Development and Implementation: Develop and implement the strategy for Document Control and Training processes to drive sustained compliance of cGMP/GDP activities. Develop and implement comprehensive Global Document Control and Training processes, including policies, procedures, and systems. Own the technical content and sustainability of the Document Control and Training processes, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents. Establish and maintain a framework for document management and training delivery including creation, review, approval, revision, storage, and obsolescence. Ensure that the processes 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 and Training processes. Establish and monitor key performance indicators (KPIs) to assess process effectiveness. Conduct regular audits and assessments to ensure compliance with internal and external requirements. Identify and mitigate risks associated processes. 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 (Veeva) and learning management systems. Ensure systems meet the needs of the organization and supports efficiency and agility. Manage system access, security, and data integrity. Training and Communication: Develop and deliver training programs on process policies and procedures. Promote a culture of quality and compliance across the organization. Communicate 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 and training needs are met. Partner with senior management to align processes with business objectives. Manage relationships with external vendors and service providers. Monitor industry trends and best practices in document control and training. Identify opportunities for process improvement and innovation. Implement changes to enhance the efficiency and effectiveness of the document control and training processes. Qualifications 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 Benefits and Equal Opportunity
Salary range: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary bonuses, stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For more information, visit the Kite/ Gilead benefits page.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response. Kite is based in Santa Monica, CA. Website: kitepharma.com. Equal Employment Opportunity
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status, or other protected characteristics. Reasonable accommodation requests may be directed to ApplicantAccommodations@gilead.com. Our environment respects individual differences and celebrates the individuals who make up our team.
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