Senior Manager, Quality Assurance, Computer System Validation (CSV)

Location
Boston, MA, United States
Posted
Feb 27, 2021
Ref
206940B0C7
Required Education
Bachelors Degree
Position Type
Full time
Title: Senior Manager, Quality Assurance, Computer System Validation

Reporting to: Associate Director, Quality Assurance, Computer System Validation

Job Summary:

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Orchard is a fast-growing and well-funded company with ground-breaking science, a commercial product and a broad pipeline that includes several assets in early and late stage clinical development.

This position is responsible for compliance oversight of computer system validation projects as part of quality assurance team.

Key Elements and Responsibilities:
  • Provide quality oversight to computer system validation projects for implementation and maintenance of computer systems
  • Work with validation lead to determine validation deliverables
  • Provide input to validation documentations
  • Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
  • Perform risk assessments with functional teams to assess system risks and develop mitigations
  • Oversee the execution of qualification/validation activities
  • Participate in vendor assessments and/or audits
  • Manage and/or lead CSV routine and complex audits including but not limited to internal processes, vendors and business partners.
  • Works closely with the QA function to provide expert CSV compliance information, manage identified issues, and support continuous improvement.
  • perform CSV inspection readiness preparations and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable
  • Update and/or create computer system related policies, procedures, templates, forms, etc.
  • Provide input to GxP assessments for 21 CFR Part 11 and Annex 11 requirements
  • Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations
  • Review and approve computer system change controls, discrepancies, CAPAs
  • Review and provide feed to vendor validation documentations (Validation plan, executed protocols, risk assessments)
  • Ensure completion of training for applicable validation activities


Requirements

Qualifications:
  • Experience working in biotech/pharmaceutical industry
  • A minimum of a bachelor's degree in engineering, science or equivalent technical discipline is required.
  • Extensive experience in quality assurance, computer system validation/qualification
  • Strong knowledge in CFR 21 Parts 11, GAMP5, Annex 11 electronic record/electronic signature, and data integrity requirements, standards and guidelines.
  • Strong background and understand of MHRA, FDA and other regulations.
  • Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
  • Experience in authoring/reviewing/approving validation documentation.
  • Experience in reviewing audit trail and system administration records
  • Working knowledge of software development lifecycle (SDLC) model.
  • Knowledge in validation practices of various computerized systems (configurable software, non-configurable software, off-the-shelf software).
  • Excellent written and verbal communication skills ability to work with multiple cross functional teams.
  • Data migration experience
  • Awareness of clinical systems
  • Experience with vendor audits, quality agreements
  • Ability to manage multiple projects