Associate Director - Site Data Integrity Lead (Quality Systems) This leadership role is responsible for ensuring the quality, integrity, and regulatory compliance of Gx P computerized systems across manufacturing, laboratory, and warehouse environments within a modern biopharmaceutical facility.
The position will focus on data governance, computer system validation, and quality oversight of digital systems used in regulated operations.
Responsibilities: Quality Systems & Data Integrity: Implement and maintain global quality and data integrity standards across all Gx P systems Provide QA governance for IT, manufacturing, warehouse, and laboratory systems.
Oversee policies and procedures related to CSV and data management.
Perform risk assessments, inspections, and floor-based monitoring to ensure regulatory compliance (e.g., c GMP, 21 CFR Part 11, Annex 11).
Ensure robust documentation and management of validation, change control, deviations, and CAPA processes.
Lead data governance initiatives including mapping, lifecycle management, and KPI monitoring.
Support digital systems including MES, Delta V, DCS, LIMS, ELN, SAP, and other enterprise platforms.
Computer System Validation (CSV): Ensure Gx P systems meet CSV requirements and align with global regulatory expectations.
Oversee the validation lifecycle including planning, testing (IQ/OQ/PQ), and periodic reviews.
Review and approve validation documentation and risk-based approaches.
Regulatory Compliance & Inspection Readiness: Act as Quality SME for data integrity and computerized systems during audits and inspections.
Maintain inspection readiness across supported systems.
Monitor evolving regulations and update site policies accordingly.
Support audit preparation, execution, and follow-up activities.
Continuous Improvement & Strategy: Identify and drive improvements in system integration, data flow, and validation practices.
Support digital transformation initiatives focused on data visibility and compliance.
Align local practices with broader organizational strategies and data governance frameworks.
Training & Leadership: Deliver training on data integrity, CSV, and regulatory compliance.
Mentor internal teams to build expertise in quality oversight of computerized systems.
Promote a culture of compliance and continuous learning.
Requirements: Bachelor's or advanced degree in Science, Engineering, Computer Science, Quality, or related field.
Advanced degrees (MSc, Ph D) are advantageous.
10+ years in quality assurance, CSV, or data governance within a regulated life sciences environment.
In-depth knowledge of global regulatory expectations (FDA, EMA, MHRA, etc.) Experience with Gx P laboratory and manufacturing systems (e.g., LIMS, ELN, MES, Delta V).
Proficiency in GAMP 5, QRM, and digital system compliance.
Strong leadership, communication, and cross-functional collaboration skills.
Skills: CSV LIMS QMS Quality Management Systems