Assoc Director, Global Quality Systems - Change Management
United States - Maryland - Frederick, United States - California - Santa MonicaQualityRegularDescription de l'emploi
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