Manager, Change Control and Qualification

Job description

Together We Innovate. Together We Change. Are you passionate about quality, compliance, and driving meaningful changes across complex systems? If you have a bachelor’s degree or at least eight years of experience in change control, product/process qualification, validation, or quality systems in a regulated environment, we want to speak with you! We are currently seeking a Manager, Change Control and Qualification to join our Quality organization in Richmond, VA, Nashville, TN or Hopkinsville, KY in a hybrid work arrangement.

Relocation benefits will be provided.

What you will be doing

• Drives portfolio-level decisioning rigor by establishing review cadences, arbitrating cross-functional conflicts, and approving dispositions for high-risk changes. Holds approval authority for changes affecting qualified state within assigned scope, and monitors risk outcomes across the change portfolio.
• Drives documentation control performance through governance and metrics, analyzing recurring defects in change and qualification records and implementing corrective standards that prevent them from repeating.
• Drives governance effectiveness by improving forums, resolving systemic bottlenecks, and standardizing change control and qualification execution across teams and sites. Reports cycle time, backlog, and quality performance to Quality leadership.
• Aligns platform stakeholders across functions to improve decision quality, reduce recurring impact gaps, identify and inform regulatory compliance questions and reporting, and prioritizes system enhancement requests with system owners.
• Manages a team of change control and qualification professionals. Sets performance expectations and objectives, allocates work across the portfolio, develops technical depth in both disciplines, and conducts performance and development conversations.

We want you to have:

• Bachelor’s or Advanced Degree preferred
• 8+ years of experience in a regulated environment with change control understanding documents
• Understanding of FDA and other regulatory processes
• Advanced written and editorial skills, and strong attention to detail.
• Demonstrated ability to synthesize complex information using excellent critical thinking skills while using risk based decision making
• Strong communication and organizational skills and proven ability to meet timelines.