Data Integrity SME: Quality & Manufacturing (GMP)

United Pharma; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma is seeking an experienced Data Integrity Subject Matter Expert to support Quality and Manufacturing operations in a regulated pharmaceutical environment. The role emphasizes ALCOA+ compliance, regulatory alignment, and continuous improvement of Data Integrity controls across GMP processes.

The candidate will collaborate with QA, Manufacturing, QC, Validation, IT, and CSV teams to ensure robust data governance, investigations, CAPAs, and evidence-based decision making in line with

Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Biotechnology, or a related discipline.
• 8+ years of experience in the pharmaceutical, biotechnology, biologics, or other regulated life sciences industries.
• 5+ years of direct experience in Data Integrity, Quality Assurance, Manufacturing Quality, Compliance, or related GMP functions.
• Strong hands-on experience supporting GMP Manufacturing and Quality operations.
• Extensive knowledge of Data Integrity principles and ALCOA+ requirements.
• Strong understanding of FDA Data Integrity expectations and current regulatory guidance.
• Experience with 21 CFR Part 11, EU GMP Annex 11, and electronic records/electronic signatures requirements.
• Experience performing Data Integrity gap assessments and risk assessments.
• Demonstrated experience leading or supporting Data Integrity remediation programs.
• Strong experience with deviation investigations, root cause analysis, CAPA, and quality risk management.
• Knowledge of Good Documentation Practices (GDP) and GMP documentation requirements.
• Experience evaluating Data Integrity controls for both paper-based and electronic records.
• Knowledge of audit trails, audit trail review, user access management, electronic data security, and data lifecycle management.
• Experience working with cross-functional teams, including QA, Manufacturing, QC, Validation, Engineering, Automation, and IT.
• Strong understanding of computerized systems and their impact on GMP Data Integrity.
• Excellent written, verbal, analytical, and problem-solving skills.
• Ability to independently manage multiple priorities in a fast-paced manufacturing environment.

Responsibilities

• Serve as the Subject Matter Expert (SME) for Data Integrity across Quality and Manufacturing operations.
• Lead Data Integrity assessments to identify gaps, vulnerabilities, risks, and compliance concerns within GMP processes and systems.
• Ensure compliance with ALCOA+ principles across data attributes and records.
• Develop, review, and implement Data Integrity policies, procedures, standards, and governance programs.
• Perform risk assessments to evaluate Data Integrity risks in GMP processes, paper records, electronic systems, and instruments.
• Support Data Integrity remediation plans, including CAPAs and sustained corrective actions.
• Investigate Data Integrity deviations, discrepancies, incidents, and potential data manipulation concerns.
• Provide technical and compliance support for deviation investigations, root cause analysis, CAPA, and effectiveness checks.
• Review manufacturing and quality records to identify Data Integrity gaps and ensure controls are implemented.
• Partner with Manufacturing, QA, QC, Validation, Engineering, and IT to strengthen Data Integrity controls.
• Assess electronic systems for access controls, audit trails, electronic signatures, security, backup, and retention.
• Review and evaluate audit trail functionality and audit trail review procedures for GMP computerized systems.
• Support compliance with 21 CFR Part 11, EU GMP Annex 11, and data integrity guidance.
• Evaluate data lifecycle controls from creation to archiving.
• Support Data Integrity requirements during implementation, upgrade, validation, and maintenance of computerized systems.
• Work with CSV/CSA teams to ensure Data Integrity controls throughout their lifecycles.
• Review SOPs and GMP documentation for Data Integrity compliance.
• Identify gaps in documentation practices and recommend sustainable improvements.
• Support internal audits, client audits, and regulatory inspections related to Data Integrity and GMP compliance.
• Prepare audit responses, remediation strategies, and supporting documentation for identified observations.
• Assist with inspection readiness activities and represent Data Integrity during regulatory inspections.
• Develop and deliver Data Integrity training programs for Manufacturing, Quality, Laboratory, and supporting functions.
• Provide coaching and guidance on good documentation practices and Data Integrity expectations.
• Establish and monitor Data Integrity metrics and KPIs.
• Participate in cross-functional governance meetings and communicate Data Integrity risks and remediation progress to leadership.
• Support continuous improvement initiatives to strengthen Quality Culture and Data Integrity awareness across the organization.
• Ensure all activities comply with GMP, cGMP, FDA, EMA, MHRA, and other regulatory requirements.

Skills

Data Integrity

ALCOA+

GMP/cGMP

Regulatory requirements

Cross-functional collaboration

Investigations & CAPA

Risk assessment

Documentation practices

Education

Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Biotechnology, or related discipline

Tools

LIMS

MES

ERP

SCADA

DCS

Historian

Empower

TrackWise

Veeva

SAP

Job description

United Pharma is seeking an experienced Data Integrity Subject Matter Expert to support Quality and Manufacturing operations in a regulated pharmaceutical environment. The role emphasizes ALCOA+ compliance, regulatory alignment, and continuous improvement of Data Integrity controls across GMP processes.

The candidate will collaborate with QA, Manufacturing, QC, Validation, IT, and CSV teams to ensure robust data governance, investigations, CAPAs, and evidence-based decision making in line with