Responsibilities
- Act as the site Validation Lead and Point of Contact for all validation and qualification activities related to facilities, utilities, production equipment, laboratories, and computerized systems.
- Lead and execute computerized Systems Validation (CSV) in accordance with GAMP 5, SDLC methodologies, and 21 CFR Part 11, including validation of MES, LIMS, ERP, DCS, PLC/SCADA, and cloud-based systems.
- Provide hands-on leadership in process equipment validation, including IQ/OQ/PQ, cleaning validation, and process validation for highly automated manufacturing environments.
- Interpret and apply global regulatory requirements, including US FDA, EU GMP, ICH, PIC/S, and local regulatory expectations, with particular emphasis on 21 CFR Parts 11, 210, 211, and 820.
- Serve as the Data Integrity Governance Lead, responsible for review, approval, and oversight of all data integrity-related activities, periodic assessments, remediation plans, and compliance metrics reporting to senior management.
- Develop, enhance, and maintain a robust Data Integrity Knowledge Base, identifying training gaps and acting as the SME for enterprise-wide training initiatives.
- Drive GMP culture and continuous improvement, promoting regulatory compliance, inspection readiness, and operational excellence across manufacturing and laboratory operations.
- Review, approve, and author complex validation documentation, including VMPs, URS, FRS, RA, protocols, reports, SOPs, and periodic review documentation.
- Lead and support regulatory inspections, internal audits, and external audits, including direct interaction with inspectors and response to observations, deviations, and CAPAs.
- Design and deliver validation and compliance training programs for site personnel and cross-functional stakeholders.
- Provide expert support for change management, deviation investigations, risk assessments, and root cause analysis related to validated systems.
Requirements
Minimum 7 to 12 years of progressive experience in regulated pharmaceutical, biotechnology, or medical device environments, with demonstrated leadership in:
- Validation & Qualification.
- Computerized Systems Validation (CSV)
- SDLC & Change Management
- Manufacturing Quality Systems
- Data Integrity Governance
- Audit & Inspection Readiness
- Deviation Management, CAPA, and Documentation Control
- Bachelor's or Master's degree in Engineering, or a related technical discipline.
- Six Sigma Green Belt or Black Belt certification - Preferred (project prerequisite).
- GMP & GDP certification good to have
- Deep working knowledge of international regulatory standards and guidance, including but not limited to: US FDA, EU GMP, PIC/S, PDA21 CFR Parts 11, 210, 211, 820ISPE, GAMP 5, BPE
- Proven hands-on expertise in data integrity frameworks, risk-based validation approaches, and remediation of regulatory findings.
- Demonstrated ability to function as a senior SME, influencing stakeholders across Quality, Engineering, IT, Manufacturing, and Regulatory Affairs.
- Strong documentation, communication, and regulatory inspection handling skills.
