Change Control Analyst

Job Description

Key Responsibilities:

• Support process changes arising from updates to materials, excipients or finished goods requirements.
• Support the CAR T facilities, engineering, maintenance, C&Q site change control process.
• Identify the needs of the engineering, maintenance, C&Q teams and submit the request for a change.
• Be a Subject Matter Expert for the facilities changes.
• Act as change control champion by being responsible for the change control prior to Initiation through completion.
• Participate in change control meetings.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Develop and manage change strategies and plans aligned with project objectives, including timelines, resources, and risk mitigation.
• Assess impacts and risks of proposed changes, identify stakeholders, and plan mitigation strategies.
• Coordinate with project managers, leaders, and cross-functional teams to integrate change activities into project plans.
• Facilitate communication — design, deliver, and manage key messages to keep stakeholders informed and engaged.
• Support training and enablement for staff affected by changes, including coaching managers and team members.
• Monitor progress and adoption, track metrics, and report on issues, risks, and outcomes.
• Address resistance and implement corrective actions to improve adoption and performance.
• Document and maintain records of all change management activities for audit and future reference.

Skills and Requirements

Facilities change control experience familiarity with CART environment

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].