Associate Director, Quality Assurance Computer Systems Validation (CSV)

Associate Director, Quality Assurance Computer Systems Validation



Location: Boston, MA



Reporting to: Director Corporate QA



Job summary



Reporting to the Director of Corporate Quality Assurance, the role will lead the Orchard Therapeutics Computer Systems Validation Quality Assurance function. The role will oversee the development of robust systems to support qualification and validation efforts of computer systems as well as maintaining Sponsor oversight of vendor computer systems used.



Expertise in FDA, Eudralex, GAMP, ICH, and industry best practices associated with Computer Systems is a must. This is an exciting opportunity to shape the future of the Orchard organization by leading and building the QA Computer Systems Validation function.



Key Elements and Responsibilities



* Being the QA Subject Matter expert and representative for internal validation projects.

* Partner with IT to develop and maintain the Orchard Computer Systems Validation processes including establishment and/or refinement of policy, procedures, and work instructions.

* Partner with IT to develop a world-class, risk-based Computer Systems Validation (CSV) Program.

* Oversee the execution of User Acceptance Testing for newly acquired Computer Systems.

* Develop and/or execute the Risk assessment of newly acquired Computer Systems.

* Review the reports in support of executed validation test script protocols.

* Ensure GXP computer systems audits are being performed in accordance to an established audit programme for both inhouse and vendor systems used.

* Experienced in U.S. and EU Data Integrity and General Data Protection Regulation (GDPR) regulations.

* Support software vendor qualification activities including risk assessments and due diligence audits.

* Provide Quality Assurance Computer Systems validation support to Orchard Operations organizations.

* Quality Assurance approval authority of change controls and computer systems validation documents including Impact Assessments, Action Plans, and Risk Assessments, Protocols, and Reports.

* Participate in the development of Orchards IT data governance policies and procedures.

* Oversee Periodic Review of Orchard Computer Systems.

* Driving Company CSV Inspection readiness activities ensuring Company Inspection readiness state is maintained for CSV.

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Requirements



Required knowledge



* 10+ years of experience in a GXP environment, with 5+ years in CSV.

* Experience in the pharmaceutical, biotechnology, or gene therapy industry.

* Travel up to 20%.



Skills and Abilities



* Expert in Computer System Validation

* Expert in GAMP5, 21 CFR Part 11, Annex 11

* Expert Knowledge of IQ/OQ/PQ

* Experience in GXP Environment

* Experience with implementation and continuous improvement of Quality Systems supporting CSV

* Experience with vendor audits

* Experience with implementation and validation of computer systems to support a new facility design, commissioning, qualification

* Ability to communicate well across different disciplines and experience levels.

* Experience supporting regulatory inspections

* Experience using risk management tools (FMEA, etc.)

* Knowledgeable in Software Development Lifecycle (SDLC)



Education



* Bachelors Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).