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Data Integrity Director
hace 2 meses
We are seeking a seasoned professional to lead our Data Integrity Program in Guadalajara, Mexico. Our client, a commercial organization with over 75 years of experience, specializes in the development, manufacturing, and sterilization of complex medical devices and pharmaceutical products.
Key Responsibilities
- Develop and implement a comprehensive data integrity governance program, providing strategic leadership for the establishment of a robust data integrity program based on risk analysis.
- Lead the escalation of all data integrity-related issues to site management levels as needed.
- Provide oversight for the governance, management, and coordination of activities related to the Data Integrity Program, including leading, developing, and maintaining data integrity compliance activities throughout the product lifecycle in alignment with regulations and GMP guidelines.
- Drive continuous and sustainable improvement in data integrity risk detection and mitigation through self-inspection programs, continuous improvement programs, Gemba walks, etc.
- Identify training needs, design, develop, and deliver data integrity training on a regular frequency.
- Ensure compliance with all regulatory requirements related to data integrity, company policies, and procedures, including security rules and regulations.
- Interact directly with FDA, other regulatory agencies, and auditors on all issues related to data integrity, including supporting preparation for customer inspections, health authorities, and responding to observations during audits.
Requirements and Qualifications
- Bachelor's Degree plus 10 years of experience in the pharmaceutical/biopharmaceutical industry supporting manufacturing and quality operations.
- Experience and in-depth knowledge of GxP computerized systems validation and 21 CFR Part 11, GAMP 5, and CSV requirements, including cloud systems, agile software development validation, methods validation, and IT infrastructure qualification.
- Experience in FDA-regulated environments, including US 21 CFR Part 210 & 211 Current Good Manufacturing Practice, and dealing directly with FDA.
- Cross-functional experience in the pharmaceutical industry regulated by GxPs, including manufacturing, engineering, quality assurance, quality control, etc.
- Direct experience related to data integrity in the pharmaceutical/biopharmaceutical industry, with strong experience in data integrity program support, risk analysis, project, and budget management.
- In-depth knowledge of data integrity requirements, including US FDA, UK MHRA, PIC/s, EU, TGA, etc.
- In-depth knowledge in validation of computerized GxP systems and requirements of 21 CFR Part 11, GAMP 5, and data integrity guidelines of US FDA, UK MHRA, PIC/s, EU, TGA, etc.
- Expert-level knowledge and understanding of cGMP.
Pharmatech Associates, Inc. is an equal employment opportunity employer, providing opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.