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.
