Head of Validation & Data Integrity

ADP, Inc.; Philadelphia (Philadelphia County); On-site; USD 120,000 - 150,000; Full time

Job summary

ADP, Inc. is seeking a Manager of Validation & Data Integrity to lead lifecycle validation and data integrity programs for equipment, utilities, and GMP processes within the USWM CT production facility in Philadelphia.

This role provides leadership to the Validation team, ensuring compliance with cGMPs and global regulatory expectations. The candidate will oversee VMPs and data integrity plans, drive risk assessments, support regulatory inspections, and maintain inspection readiness across

Qualifications

• Bachelor’s degree in science or related technical field is required.
• 7–10 years of validation or related experience in biotech/pharma industries with leadership or supervisory experience.
• Strong understanding of cGMPs, regulatory guidance, and multinational biopharmaceutical regulations.
• Experience developing and implementing data integrity programs and remediation strategies.
• Experience with Quality Risk Management principles and FMEA.
• Proven ability to lead cross-functional teams and manage multiple complex projects.
• Strong organizational, communication, and leadership skills; ability to influence at all levels.
• Experience with quality systems supporting validation and data integrity activities (Document Management, Training, Deviation Management, Change Control, CAPA).
• Hands-on experience with equipment qualification, utilities, automation, single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Knowledge of facility/cleanroom design, aseptic processing, and validation of aseptic operations.
• Experience with aseptic manufacturing and validation of aseptic processes.
• Experience with cell and gene therapies or biologics products.
• Experience with external parties and cross-functional teams.

Responsibilities

• Lead the development, approval, and maintenance of Validation Master Plans (VMPs) and Data Integrity Governance Plans.
• Oversee validation deliverables including URS, FS/DS, risk assessments, IQ/OQ/PQ protocols, and data integrity assessments.
• Direct planning and execution of validation activities; resolve deviations and data integrity issues.
• Maintain data integrity controls aligned with ALCOA+ across systems and processes.
• Coordinate cross-functional teams to ensure validation supports operational readiness.
• Apply Quality Risk Management and lead FMEA-driven validation decisions.
• Identify opportunities to improve validation practices and documentation quality.
• Ensure validation work complies with regulations, cGMPs, and USWM policies.
• Provide oversight for ongoing qualification and remediation at internal/external sites.
• Lead change control impact assessments to maintain validated state and data integrity.
• Maintain inspection readiness and serve as SME during inspections and audits.
• Participate in CAPA, Deviation, and Change Control meetings; provide leadership.
• Collaborate on aseptic process validation strategies and aseptic operations.

Skills

Leadership

Communication

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s Degree in Science or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

ADP, Inc. is seeking a Manager of Validation & Data Integrity to lead lifecycle validation and data integrity programs for equipment, utilities, and GMP processes within the USWM CT production facility in Philadelphia.

This role provides leadership to the Validation team, ensuring compliance with cGMPs and global regulatory expectations. The candidate will oversee VMPs and data integrity plans, drive risk assessments, support regulatory inspections, and maintain inspection readiness across