Data Integrity SME – Quality Manufacturing

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

We are seeking an experienced Data Integrity Subject Matter Expert (SME) to support Quality and Manufacturing operations within a regulated pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in Data Integrity (DI), GMP/cGMP compliance, quality systems, manufacturing processes, investigations, remediation, and regulatory requirements.

The Data Integrity SME will lead and support initiatives related to the assessment, remediation, implementation, and continuous improvement of Data Integrity controls across manufacturing and quality operations. This individual will work closely with Quality Assurance, Manufacturing, QC, Engineering, Validation, IT/CSV, and other cross-functional teams to ensure that electronic and paper-based records comply with applicable regulatory requirements and ALCOA+ principles

Key Responsibiliti

• esServe as the Subject Matter Expert (SME) for Data Integrity across Quality and Manufacturing operation
• s.Lead Data Integrity assessments to identify gaps, vulnerabilities, risks, and compliance concerns within GMP processes and system
• s.Ensure compliance with ALCOA+ principles, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available dat
• a.Develop, review, and implement Data Integrity policies, procedures, standards, and governance program
• s.Perform risk assessments to evaluate Data Integrity risks associated with GMP processes, paper records, electronic systems, instruments, and computerized system
• s.Support the development and execution of Data Integrity remediation plans, including CAPAs and sustainable corrective action
• s.Investigate Data Integrity deviations, discrepancies, incidents, and potential data manipulation concern
• s.Provide technical and compliance support for deviation investigations, root cause analysis, CAPAs, and effectiveness check
• s.Review manufacturing and quality records to identify potential Data Integrity gaps and ensure appropriate controls are implemente
• d.Support batch record review and evaluate GMP documentation practices for completeness, accuracy, traceability, and complianc
• e.Partner with Manufacturing, Quality Assurance, QC, Validation, Engineering, and IT teams to strengthen Data Integrity control
• s.Assess electronic systems and computerized systems for appropriate user access controls, audit trails, electronic signatures, security, backup, and record retentio
• n.Review and evaluate audit trail functionality and audit trail review procedures for GMP computerized system
• s.Support compliance with 21 CFR Part 11, EU GMP Annex 11, and applicable Data Integrity guidanc
• e.Evaluate data lifecycle controls, including data creation, processing, review, approval, storage, backup, retrieval, retention, and archiva
• l.Support Data Integrity requirements during implementation, upgrade, validation, and maintenance of computerized system
• s.Work with CSV/CSA teams to ensure computerized systems maintain appropriate Data Integrity controls throughout their lifecycl
• e.Review SOPs, work instructions, protocols, reports, and GMP documentation for Data Integrity complianc
• e.Identify gaps in documentation practices and recommend practical, sustainable process improvement
• s.Support internal audits, client audits, and regulatory inspections related to Data Integrity and GMP complianc
• e.Prepare audit responses, remediation strategies, and supporting documentation for identified observation
• s.Assist with inspection readiness activities and represent the Data Integrity function during regulatory inspections, as require
• d.Develop and deliver Data Integrity training programs for Manufacturing, Quality, Laboratory, and supporting function
• s.Provide coaching and guidance to personnel regarding good documentation practices and Data Integrity expectation
• s.Establish and monitor Data Integrity metrics, trends, and key performance indicator
• s.Participate in cross-functional governance meetings and communicate Data Integrity risks and remediation progress to leadershi
• p.Support continuous improvement initiatives to strengthen Quality Culture and Data Integrity awareness across the organizatio
• n.Ensure all activities are performed in accordance with GMP, cGMP, FDA, EMA, MHRA, and other applicable regulatory requirement

s.Required Qualificati

• onsBachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Biotechnology, or a related discipli
• ne.8+ years of experience in the pharmaceutical, biotechnology, biologics, or other regulated life sciences indust
• ry.5+ years of direct experience in Data Integrity, Quality Assurance, Manufacturing Quality, Compliance, or related GMP functio
• ns.Strong hands-on experience supporting GMP Manufacturing and Quality operatio
• ns.Extensive knowledge of Data Integrity principles and ALCOA+ requiremen
• ts.Strong understanding of FDA Data Integrity expectations and current regulatory guian
• ce.Experience with 21 CFR Part 11, EU GMP Annex 11, and electronic records/electronic signatures requiremen
• ts.Experience performing Data Integrity gap assessments and risk assessmen
• ts.Demonstrated experience leading or supporting Data Integrity remediation progra
• ms.Strong experience with deviation investigations, root cause analysis, CAPA, and quality risk manageme
• nt.Knowledge of Good Documentation Practices (GDP) and GMP documentation requiremen
• ts.Experience evaluating Data Integrity controls for both paper-based and electronic recor
• ds.Knowledge of audit trails, audit trail review, user access management, electronic data security, and data lifecycle manageme
• nt.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 Integri
• ty.Excellent written, verbal, analytical, and problem-solving skil
• ls.Ability to independently manage multiple priorities in a fast-paced manufacturing environme

nt.Preferred Qualificat

• ionsPrevious experience serving as a Data Integrity SME or Data Integrity Program L
• ead.Experience supporting pharmaceutical manufacturing facilities subject to FDA, EMA, MHRA, or other global regulatory inspecti
• ons.Experience responding to regulatory observations, including Data Integrity-related findi
• ngs.Knowledge of GAMP 5 and computerized system validation (CSV) or Computer Software Assurance (CSA) princip
• les.Experience with Quality Management Systems such as deviations, CAPA, change control, complaints, and audit managem
• ent.Experience with electronic systems such as LIMS, MES, ERP, SCADA, DCS, Historian, Empower, TrackWise, Veeva, SAP, or similar GMP applicati
• ons.Experience with data governance, Data Integrity maturity assessments, and Quality Culture initiati
• ves.Strong knowledge of ICH Q9 Quality Risk Management and pharmaceutical quality system princip