Manager, 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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Manager, Validation & Data Integrity

Full Time FT40 Full-Time Philadelphia, PA, US

SUMMARY: This role is responsible for leading the strategy, governance, and execution of validation and data integrity programs across equipment, utilities, computerized systems, and GMP manufacturing processes within the USWM ‑ CT production facility. The Manager, Validation and Data Integrity, provides leadership to the Validation team, ensuring compliance with cGMP, global regulatory expectations, and USWM policies. This role will drive lifecycle validation programs, oversee change control and risk management processes, support regulatory inspections, and ensure the manufacturing facility remains in a state of continuous compliance and inspection readiness.

DUTIES AND 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 and oversee validation and data integrity deliverables including URS, FS/DS, risk assessments, IQ/OQ/PQ protocols, Part 11/Annex 11 assessments, data flow maps, and summary reports.
• Direct the planning and execution of validation and qualification activities, ensuring deviations, investigations, data integrity issues, and technical issues are resolved promptly and effectively.
• Establish and maintain data integrity controls aligned with ALCOA+ principles across computerized systems, manufacturing processes, and quality systems.
• Manage cross ‑ functional coordination with QA, Manufacturing, Process Development, QC, Facilities, and IT teams to ensure validation activities support operational readiness.
• Apply Quality Risk Management principles and lead the use of risk assessment tools (e.g., FMEA) to support validation decisions and prioritization.
• Identify opportunities for continuous improvement and implement enhancements to validation practices, data integrity controls, documentation quality, and operational efficiency.
• Ensure all validation and data integrity work is performed in accordance with applicable regulations, cGMPs, industry guidelines, and USWM policies and procedures.
• Provide oversight and support for ongoing qualification, requalification, data integrity remediation and validation activities at internal and external manufacturing sites.
• Lead and approve change control impact assessments for process, equipment, utilities, facilities, and computerized systems, ensuring validated state and data integrity are maintained.
• Maintain inspection readiness and serve as a subject matter expert (SME) during regulatory inspections, internal audits, and external audits.
• Participate in routine operational meetings (CAPA, Deviation, Change Control) and provide Validation leadership and decision ‑ making support.
• Collaborate on aseptic process validation strategies, ensuring compliance with facility design, cleanroom requirements, and aseptic manufacturing standards.
• Lead, mentor, and develop the Validation team, ensuring strong technical capability, effective workload management, and high performance.

QUALIFICATIONS:

Required

• Bachelor’s Degree in Science or related technical field.
• Minimum of 7–10 years of validation, or related experience in biotechnology or pharmaceutical industries, including leadership or supervisory experience.
• Strong understanding of cGMPs, regulatory guidance, and multinational biopharmaceutical/cell therapy regulations.
• Deep knowledge of global regulatory requirements for Clinical and Commercial GMP 210/211, and 21 CFR Part 11.
• Experience developing and implementing data integrity programs and remediation strategies.
• Experience with Quality Risk Management principles and performing risk assessments using tools such as FMEA.
• Proven ability to lead cross ‑ functional teams and manage multiple complex projects in a fast ‑ paced environment.
• Strong organizational, communication, and leadership skills with the 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.
• Proficiency in Microsoft Word, Excel, PowerPoint.
• Experience with Calibration manager databases, Electronic Lab Notebooks, Quality Management systems, Document Control software
• Experience with leading the start-up, validation, and licensure of manufacturing facilities.
• Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation).
• Experience working with cell and gene therapies or biologics products.
• Experience working with external parties and/or leading cross-functional teams

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet.
• Aseptic Gowning is a requirement when executing validation work on the floor.