Associate Director, Quality Assurance Computerized Systems Validation

Location
Menlo Park, CA, US
Posted
Jul 27, 2019
Ref
9CDFA73277
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Location: Menlo Park, CA

Reporting to: Senior Vice President of Global Quality and GxP Compliance

Job summary

Reporting to the Senior Vice President of Global Quality Assurance and GxP Compliance, the role will lead the establishment of the Orchard Therapeutics Computerized Systems Validation Program. The role will oversee the development of robust systems to support qualification and validation efforts of computerized systems.

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

Key Elements and Responsibilities
  • Maintain the Orchard Computerized Systems Validation processes including establishment and/or refinement of policy, procedures, and work instructions.
  • Partner with IT to develop a world-class, lean Computer Systems Validation (CSV) Program.
  • Oversee the execution of User Acceptance Testing for newly acquired Computerized Systems.
  • Develop and/or execute the protocols in support of the validation of newly acquired Computerized Systems.
  • Write/Review the reports in support of executed validation test script protocols.
  • Ensure GXP computer systems are validated and operate within a state of compliance.
  • Experienced in U.S. and EU Data Integrity and General Data Protection Regulation (GDPR) regulations
  • Support software vendor qualification and auditing.
  • Provide Quality Assurance Computerized Systems validation support to the Technical Operations organization.
  • Quality Assurance approval authority of change controls and computerized systems validation documents assessing Impact Assessment, Action Plans, and Risk Assessment.
  • Participate in the development of Orchard's IT data governance policies and procedures.

Requirements

Requirements
  • 10+ years of experience in a GXP environment, with 5+ years in CSV.
  • 3+ years of management experience.
  • Experience in the pharmaceutical, biotechnology, or gene therapy industry.
  • Travel up to 20%
  • Expert in Computer System Validation
  • Expert Knowledge of IQ/OQ/PQ
  • Expert best practices for aseptic practices and contamination control
  • Experience building and leading a team
  • Experience in GXP Environment
  • Experience with vendor audits
  • Experience with implementation and validation of computerized 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.)
  • Bachelor's Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).


Education
  • Bachelor's Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).

Benefits

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify