Associate Director - Site Data Integrity Lead

Associate Director - Site Data Integrity Lead (Quality Systems)

This leadership role is responsible for ensuring the quality, integrity, and regulatory compliance of GxP 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 GxP 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., cGMP, 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, DeltaV, DCS, LIMS, ELN, SAP, and other enterprise platforms.

Computer System Validation (CSV):

• Ensure GxP 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, PhD) 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 GxP laboratory and manufacturing systems (e.g., LIMS, ELN, MES, DeltaV).
• Proficiency in GAMP 5, QRM, and digital system compliance.
• Strong leadership, communication, and cross-functional collaboration skills.