Quality Assurance Director - Computer Systems
This leadership role will play a critical part in ensuring the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.
* Develop and implement global standards for computer system quality assurance and data integrity.
* Provide quality direction and governance for QA-owned systems, site IT systems, manufacturing systems, and laboratory systems.
* Maintain quality assurance procedures, policies, and systems related to data management and CSV.
The successful candidate will work closely with cross-functional teams to support inspections, continuous improvement, and quality culture development at the site and global level.
Key Responsibilities:
Quality Systems and Data Integrity:
* Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP, data integrity, and other relevant regulations.
* Ensure accurate documentation of quality records, validation activities, and system-related compliance data.
* Oversee system change control, deviation management, CAPA, and periodic review processes.
Computer System Validation:
* Evaluate all GxP computerized systems for CSV requirements and alignment with global standards.
* Review and approve CSV deliverables, deviations, and risk-based validation strategies.
Regulatory Compliance and Inspection Readiness:
* Maintain inspection readiness across all supported systems, ensuring alignment with corporate and regulatory standards.
* Stay current with industry regulations, guidelines, and best practices.
* Assist in preparing and executing regulatory inspections and audits.
Continuous Improvement and Strategy:
* Identify areas for optimization in data flow, system integration, and validation strategies.
* Champion initiatives in digital transformation, data contextualization, and visualization to enhance decision-making and compliance.