Kite Pharma
Assoc Director, Global Quality Systems - Change Management
Kite Pharma, Frederick, Maryland, United States, 21701
Overview
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 This role can be located onsite in Santa Monica, CA or Frederick, MD or Oceanside, CA or El Segundo, CA. The role is responsible for establishing, implementing, and overseeing Kite’s Global Change Management program. This role ensures that all cGMP Changes are managed according to relevant regulations, standards, and internal policies. The role will lead the development and continuous improvement of Kite’s Change Management processes, and associated systems and training, to ensure effective, efficient and compliant management of cGMP change processes. Responsibilities
Program Development and Implementation:
Develop and implement the strategy for Change Management to drive sustained compliance of cGMP activities. Program Development and Implementation:
Develop and implement a comprehensive global Change Management program, including policies, procedures, and systems. Program Development and Implementation:
Own the technical content and sustainability of the Change Management topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents. Program Development and Implementation:
Establish and maintain a framework for change creation, review, approval, revision, and governance. Program Development and Implementation:
Ensure the program aligns with relevant regulations (e.g., FDA, ISO), industry standards, and business needs. Program Development and Implementation:
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 Change Management program. Governance and Strategic Direction:
Establish and monitor key performance indicators (KPIs) to assess program effectiveness. Governance and Strategic Direction:
Conduct regular audits and assessments to ensure compliance with document control requirements. Governance and Strategic Direction:
Identify and mitigate risks associated with change management. Governance and Strategic Direction:
Ensure alignment with applicable regulations (e.g., FDA, ISO), internal policies, and business needs. Governance and Strategic Direction:
Manage interdependencies within and across QMS Topics. Governance and Strategic Direction:
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 Change Management systems (Veeva). System Management:
Ensure system meets the needs of the organization and supports efficient and compliant workflows. Training and Communication:
Develop and deliver training programs on supporting Change Management policies and procedures. Training and Communication:
Promote a culture of quality and compliance across the organization. Training and Communication:
Communicate Change Management program updates and changes to stakeholders. Collaboration and Stakeholder Management:
Promote a Culture of Quality and Compliance across the network. Collaboration and Stakeholder Management:
Communicate and collaborate with stakeholders on Topic updates and changes. Collaboration and Stakeholder Management:
Collaborate with cross-functional teams (e.g., Quality, Regulatory, Operations, R&D) across a global network, to ensure process needs are met. Collaboration and Stakeholder Management:
Partner with senior management to align the Change Management program with business objectives. Collaboration and Stakeholder Management:
Manage relationships with external vendors and service providers. Continuous Improvement:
Monitor industry trends and best practices in Change Management. Continuous Improvement:
Identify opportunities for process improvement and innovation. Continuous Improvement:
Implement changes to enhance the efficiency and effectiveness of the Change Management program. Qualifications
Basic Qualifications:
PhD with 2+ years of related experience in a biologics or pharma organization OR Basic Qualifications:
MS/MA with 8+ years of related experience in a biologics or pharma organization OR Basic Qualifications:
BS/BA with 10+ years of related experience in a biologics or pharma organization Basic Qualifications:
High School diploma with 14+ years of related experience in a biologics or pharma organization Preferred Qualifications
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 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 Compensation and Benefits
The salary range for this position is: $165,495.00 - $214,170.00. 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. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing About Kite
Kite Pharma 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. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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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 This role can be located onsite in Santa Monica, CA or Frederick, MD or Oceanside, CA or El Segundo, CA. The role is responsible for establishing, implementing, and overseeing Kite’s Global Change Management program. This role ensures that all cGMP Changes are managed according to relevant regulations, standards, and internal policies. The role will lead the development and continuous improvement of Kite’s Change Management processes, and associated systems and training, to ensure effective, efficient and compliant management of cGMP change processes. Responsibilities
Program Development and Implementation:
Develop and implement the strategy for Change Management to drive sustained compliance of cGMP activities. Program Development and Implementation:
Develop and implement a comprehensive global Change Management program, including policies, procedures, and systems. Program Development and Implementation:
Own the technical content and sustainability of the Change Management topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents. Program Development and Implementation:
Establish and maintain a framework for change creation, review, approval, revision, and governance. Program Development and Implementation:
Ensure the program aligns with relevant regulations (e.g., FDA, ISO), industry standards, and business needs. Program Development and Implementation:
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 Change Management program. Governance and Strategic Direction:
Establish and monitor key performance indicators (KPIs) to assess program effectiveness. Governance and Strategic Direction:
Conduct regular audits and assessments to ensure compliance with document control requirements. Governance and Strategic Direction:
Identify and mitigate risks associated with change management. Governance and Strategic Direction:
Ensure alignment with applicable regulations (e.g., FDA, ISO), internal policies, and business needs. Governance and Strategic Direction:
Manage interdependencies within and across QMS Topics. Governance and Strategic Direction:
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 Change Management systems (Veeva). System Management:
Ensure system meets the needs of the organization and supports efficient and compliant workflows. Training and Communication:
Develop and deliver training programs on supporting Change Management policies and procedures. Training and Communication:
Promote a culture of quality and compliance across the organization. Training and Communication:
Communicate Change Management program updates and changes to stakeholders. Collaboration and Stakeholder Management:
Promote a Culture of Quality and Compliance across the network. Collaboration and Stakeholder Management:
Communicate and collaborate with stakeholders on Topic updates and changes. Collaboration and Stakeholder Management:
Collaborate with cross-functional teams (e.g., Quality, Regulatory, Operations, R&D) across a global network, to ensure process needs are met. Collaboration and Stakeholder Management:
Partner with senior management to align the Change Management program with business objectives. Collaboration and Stakeholder Management:
Manage relationships with external vendors and service providers. Continuous Improvement:
Monitor industry trends and best practices in Change Management. Continuous Improvement:
Identify opportunities for process improvement and innovation. Continuous Improvement:
Implement changes to enhance the efficiency and effectiveness of the Change Management program. Qualifications
Basic Qualifications:
PhD with 2+ years of related experience in a biologics or pharma organization OR Basic Qualifications:
MS/MA with 8+ years of related experience in a biologics or pharma organization OR Basic Qualifications:
BS/BA with 10+ years of related experience in a biologics or pharma organization Basic Qualifications:
High School diploma with 14+ years of related experience in a biologics or pharma organization Preferred Qualifications
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 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 Compensation and Benefits
The salary range for this position is: $165,495.00 - $214,170.00. 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. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing About Kite
Kite Pharma 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. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr