Quality Engineering & Validation Director (GxP/AI)

Planet Pharma; Durham (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

Planet Pharma seeks a Director of Quality Engineering in Durham, NC to lead Quality Engineering and Validation for GxP bioanalytical operations. You will guide the lifecycle oversight of computerized systems, lab equipment, data integrity, and IT-enabled workflows, partnering across IT, Facilities, and Lab Ops.

You will establish risk-based validation strategies, advance CSA, and drive AI/digital transformation while ensuring inspection readiness and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related technical/scientific discipline.
• 10+ years of progressive experience in Quality Engineering, Validation, Quality Assurance, or a related function within pharmaceutical, biotechnology, CRO/CDMO, or another highly regulated life-sciences environment, or equivalent demonstrated technical and transformation depth.
• No less than 5 years of direct people leadership experience, preferably including leadership of managers and/or senior technical professionals.
• Significant hands‑on experience with computerized system validation/assurance and sufficient knowledge of laboratory equipment qualification to provide effective Quality oversight.
• Demonstrated experience supporting GxP-regulated laboratory or scientific environments.
• Experience supporting regulatory inspections and sponsor/client audits.
• Experience leading significant quality, technology, digital, or organizational transformation initiatives.
• Demonstrated experience evaluating or implementing AI/ML, automation, advanced analytics, or other emerging technologies within a regulated environment.
• Experience within a CRO, bioanalytical laboratory, biologics/large-molecule organization, or similarly complex laboratory environment strongly preferred.

Responsibilities

• Lead Quality Engineering and Validation professionals, including people leaders and technical individual contributors.
• Establish and execute Quality Engineering strategies, standards, policies, and processes aligned with business objectives and evolving regulatory expectations.
• Foster a culture of quality ownership, technical excellence, continuous improvement, accountability, and appropriate risk-taking.
• Provide leadership and technical oversight for the lifecycle of GxP computerized systems, laboratory systems, software, equipment, instrumentation, and supporting technologies.
• Establish and maintain scalable, risk-based approaches to CSV and CSA based on intended use, regulated process/data criticality, actual controls, and residual risk.
• Serve as a senior Quality Engineering escalation point for complex technical, compliance, validation, and business issues.
• Partner with IT, Facilities/Engineering, Procurement and other stakeholders to embed Quality Engineering into technology and operational decisions early in the lifecycle.
• Drive continuous improvement and simplification of Quality Engineering processes to improve efficiency and scalability without compromising compliance.
• Promote the use of data, metrics, root cause analysis, and structured problem-solving to move the organization toward proactive risk reduction.
• Lead or support complex investigations involving computerized systems, data integrity, validation, automation, or technology.

Job description

Planet Pharma seeks a Director of Quality Engineering in Durham, NC to lead Quality Engineering and Validation for GxP bioanalytical operations. You will guide the lifecycle oversight of computerized systems, lab equipment, data integrity, and IT-enabled workflows, partnering across IT, Facilities, and Lab Ops.

You will establish risk-based validation strategies, advance CSA, and drive AI/digital transformation while ensuring inspection readiness and regulatory compliance.