Senior Specialist, GxP Digital Quality & Data Integrity

Location: Research Triangle Park Area, NC (On-site)

Position Overview

You will serve as a key partner to Manufacturing, Quality Control, Validation, and IT, ensuring that digital transformation and automation initiatives meet rigorous GxP regulatory standards. This is a high-impact opportunity to influence enterprise-wide digital strategies and ensure the highest levels of patient safety and product quality.

Core Responsibilities

• Validation Oversight: Lead risk-based Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities, ensuring strict adherence to 21 CFR Part 11, EudraLex Annex 11, and industry best practices.

• Lifecycle Management: Review and approve core validation deliverables, including System Impact Assessments (SIA), URS, Functional Specs, IQ/OQ/PQ protocols, and Traceability Matrices.

• Data Integrity Leadership: Act as the primary SME for ALCOA+ principles. Develop and execute data integrity gap assessments and remediation strategies across manufacturing and laboratory environments.

• Quality Management: Serve as the Quality approver for QMS records, including change controls, CAPAs, and deviations related to automated systems and digital infrastructure.

• Cross-Functional Collaboration: Partner with System Owners to deploy robust technical controls and procedural safeguards for MES, Distributed Control Systems (DCS), and cloud-based clinical systems.

• Continuous Improvement: Author and update internal policies regarding CSA/CSV, data governance, and periodic system reviews to maintain a constant state of inspection readiness.

Qualifications

• Education: Bachelor’s degree in a STEM field (Engineering, Computer Science, or Life Sciences).

• Experience: 8–10+ years of progressive experience in Quality Assurance, Validation, or IT Compliance within the pharmaceutical or biotech industry.

• Technical Knowledge: * Deep expertise in validating automated manufacturing platforms and complex laboratory instrumentation.

  • Hands-on experience with enterprise data systems (e.g., LIMS, MES, Data Historians, and Electronic Validation tools).

  • Strong understanding of cloud infrastructure validation and supplier/vendor qualification.

• Regulatory Expertise: Expert-level knowledge of FDA and MHRA data integrity guidance and risk-based validation methodologies (GAMP 5).

• Skills: Proven ability to manage competing priorities in a fast-paced environment; excellent technical writing and cross-functional communication skills.