Assoc Director, Global Quality Systems - Change Management

仕事内容

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.

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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.

• Develop and implement a comprehensive global Change Management program, including policies, procedures, and systems.

• Own the technical content and sustainability of the Change Management topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents.

• Establish and maintain a framework for change creation, review, approval, revision, and governance.

• 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 Change Management 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 change 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 Change Management systems (Veeva).

• 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.

• Promote a culture of quality and compliance across the organization.

• Communicate Change Management 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 process needs are met.

• Partner with senior management to align the Change Management program with business objectives.

• Manage relationships with external vendors and service providers.

Continuous Improvement:

• Monitor industry trends and best practices in Change Management.

• Identify opportunities for process improvement and innovation.

• Implement changes to enhance the efficiency and effectiveness of the Change Management 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:

• 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

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

* 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.

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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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.