Sr Manager Computer System Validation

Must-Have:

• 8 + years of experience working in an FDA-regulated, GMP-related environment. Pharma, Biotech, Medical Device industry.


• Implementation and change management of QMS (Quality Management System) and LIMS (Lab Information Management System).


• Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.




• Responsibilities


• Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.


• Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.


• Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements

Qualifications

• Bachelor s Degree in a Scientific or Engineering discipline with eight (8) + years of computerized system experience with IT compliance/validation/qualification activities.


• Eight (8) + years of experience working in an FDA-regulated, GxP-related environment.


• Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.


• Comprehensive knowledge in Software Validation and Data Integrity Principles.


• Demonstrated experience, results, and accomplishments in QMS (Quality Management Systems) and LIMS (Lab Information Management System) system implementations.


• Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.


• Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.


• Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)


• Knowledge of Software Risk Management Principles and tools.


• Knowledge and proven ability working with Risk Management methodologies and tools.


• Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.


• Experience with application system validation and infrastructure qualification.


• Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.


• Experience with writing and approving Standard Operating Procedures and Quality Standards.