Head of Validation & Data Integrity

USWM, LLC; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Job summary

USWM, LLC seeks a Manager of Validation & Data Integrity to lead lifecycle validation programs across equipment, utilities, and GMP processes at the CT production facility. You will oversee QA, manufacturing, IT collaboration, and risk-led decisions to ensure compliance and inspection readiness.

The role requires strong leadership, cGMP expertise, and hands-on validation experience, including data integrity controls and regulatory interactions.

Qualifications

• Bachelor’s degree in science or related field.

Responsibilities

• Lead the development, approval, and maintenance of Validation Master Plans (VMPs) and Data Integrity Governance Plans using a lifecycle approach for equipment, utilities, computerized systems, and GMP processes.
• Define validation deliverables including URS, FS/DS, risk assessments, IQ/OQ/PQ protocols, data flow maps, and summary reports.
• Direct planning and execution of validation activities, resolving deviations and data integrity issues promptly.
• Establish data integrity controls aligned with ALCOA+ across computerized systems and processes.
• Coordinate with QA, Manufacturing, Process Development, QC, Facilities, and IT to support operational readiness.
• Apply Quality Risk Management and use risk tools like FMEA to guide validation decisions.
• Identify opportunities for continuous improvement in validation practices and data integrity.
• Ensure validation work complies with regulations, cGMPs, and USWM policies.
• Provide oversight for ongoing qualification and validation activities at internal and external sites.
• Lead change control impact assessments to maintain validated state and data integrity.
• Maintain inspection readiness and act as SME during regulatory inspections and audits.
• Participate in CAPA, Deviation, and Change Control meetings and provide validation leadership.
• Collaborate on aseptic process validation strategies and cleanroom compliance.
• Lead and mentor the Validation team and manage workload and performance.

Skills

Leadership

Cross-functional leadership

Regulatory knowledge

cGMP

Data integrity

Validation

FMEA

Project management

Education

Bachelor’s in Science

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Electronic Lab Notebooks

Quality Management Systems

Document Control Software

Calibration Manager Databases

Job description

USWM, LLC seeks a Manager of Validation & Data Integrity to lead lifecycle validation programs across equipment, utilities, and GMP processes at the CT production facility. You will oversee QA, manufacturing, IT collaboration, and risk-led decisions to ensure compliance and inspection readiness.

The role requires strong leadership, cGMP expertise, and hands-on validation experience, including data integrity controls and regulatory interactions.