Associate Director, Quality Assurance Computer Systems Validation (CSV)

Other jobs >> General




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.



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)


* Bachelors Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).
  • 1
  • Negotiable
  • None
  • None
  • Re-83750
  • Permanent
  • 1

How to Apply: Please click here to create a free account and post your resume. Only logged in job seekers can apply for a job.

Find us at:

Never provide bank account, credit card details or any other financial information, or make any form of payment, when applying for a job. If you are ever asked to do this by a recruiter on Pure Jobs please click the Report button or contact us with the advertiser's company name and the title of the job vacancy. You should not send any money to anyone. A genuine employer with a job offer would never ask you to do this.

Report this job

Report a job

If you're concerned about a job advert, let us know and our quality team will investigate.

Your name(*)
Invalid Input

Your email address(*)
Invalid Input

Please select you reason(*)

Additional information(*)
Invalid Input

Invalid Input

Get new jobs for this search by email.

Also get an email with jobs recommended just for me.

Create Alert

Subscribe to updates from our blog