Validation & Data Integrity Leader - cGMP Compliance

US WorldMeds, LLC; Philadelphia (Philadelphia County); On-site; USD 130,000 - 170,000; Full time

Job summary

US WorldMeds, LLC is seeking a Manager of Validation and Data Integrity to lead strategy, governance and execution of validation across equipment, utilities, computerized systems and GMP processes at the USWMCT facility.

This role provides leadership to the Validation team, ensures cGMP compliance, regulatory readiness, and collaborates with QA, Manufacturing, Process Development, QC, Facilities and IT to support operational readiness and continuous improvement.

Qualifications

• Bachelor's degree in science or related field.
• 7–10 years validation or related biopharma experience with leadership.
• Strong knowledge of cGMPs and regulatory guidance.
• Experience developing and implementing data integrity programs and remediation.
• Experience with Quality Risk Management (FMEA).
• Ability to lead cross-functional teams in a fast-paced environment.

Responsibilities

• Lead creation and maintenance of Validation Master Plans and Data Integrity Governance Plans.
• Define and oversee validation deliverables (URS, FS/DS, IQ/OQ/PQ, Part 11 assessments).
• Plan and execute validation activities, resolve deviations and data integrity issues.
• Maintain ALCOA+ data integrity controls across systems and processes.
• Coordinate with QA, Manufacturing, and IT to support readiness and inspections.
• Lead change control impact assessments to maintain validated state.
• Mentor and develop Validation team; drive continuous improvement.

Skills

Leadership

Cross-functional leadership

Quality systems

Regulatory compliance

Data integrity

Risk management

Change control

GAMP 5

Project management

Education

Bachelor's Degree in Science

Tools

Kaye

Ellab

TempTale

Document Control software

QMS

CAPA system

Job description

US WorldMeds, LLC is seeking a Manager of Validation and Data Integrity to lead strategy, governance and execution of validation across equipment, utilities, computerized systems and GMP processes at the USWMCT facility.

This role provides leadership to the Validation team, ensures cGMP compliance, regulatory readiness, and collaborates with QA, Manufacturing, Process Development, QC, Facilities and IT to support operational readiness and continuous improvement.