The Sr. Manager, QA Validation Computerized Systems will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices.

Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements.

The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving.



Job Requirements:

FDA- Regulated, GMP- related enviornment in Biotech or Pharma or Medical Device, GAMP5, 21 CFR Part 11, EU Annex 11, cGMP, QMS, LIMS



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 and LIMS 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.

10% travel required.