Digital Compliance Specialist

Job Description An Insight Global client in the pharmaceutical industry is seeking a Data Integrity & Systems Compliance Specialist to support data integrity and enterprise systems compliance efforts. This role will focus heavily on procedure authorship, harmonization, and system documentation, owning large, complex documentation initiatives to support global SOP alignment and inspection readiness. The ideal candidate is highly organized, detail-oriented, and comfortable working independently while translating complex system and compliance requirements into clear, consistent, and audit-ready documentation. Key Responsibilities

• Serve as a documentation and procedure contributor for data integrity and enterprise laboratory systems
• Review, edit, and standardize system procedures to ensure consistency, global SOP alignment, and clear linkage to compliance and risk
• Assess new and revised procedures and evaluate downstream impacts to existing documentation
• Develop detailed, system-specific guidance (e.g., audit trail reviews, system review criteria and rationale)
• Critically evaluate procedures authored by others, identifying gaps, ambiguities, and areas for clarification
• Collaborate with system owners and cross-functional stakeholders to ensure documentation is accurate, usable, and inspection-ready
• Support compliance initiatives, including exposure to deviation management and root cause analysis We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• Demonstrated experience performing audit trail reviews or supporting data integrity review processes in a regulated (GxP) pharmaceutical or biotech environment
• Strong understanding of data integrity principles (ALCOA+) and their application in electronic systems
• Working knowledge of GMP/GXP regulations, including 21 CFR Part 11, EU Annex 11, and audit expectations
• Experience with enterprise GxP systems (e.g., LIMS, ELN, EBR, CDS, QMS, or similar validated systems)
• Ability to identify, assess, and document data integrity risks and deviations within system-generated audit trails
• Strong analytical skills with attention to traceability, completeness, and system user activity review
• Ability to work independently in quality or compliance-driven environments, managing structured review activities across multiple systems or datasets
• Experience in Computer System Validation (CSV) or ongoing system lifecycle support
• Familiarity with audit trail review tools, automation, or periodic review frameworks
• Background in Quality Assurance, Quality Systems, or Data Integrity programs
• Experience working with inspection readiness or regulatory inspections (FDA, EMA, MHRA)
• Exposure to laboratory, manufacturing, or clinical systems environments