4D Molecular Therapeutics

Powering the Future of Genetic Medicines

Associate Director, QA Computer System Validation

QA EngineerQA EngineerFull TimeRemoteTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

27 days ago

Salary

$169K - $197K / year

Bachelor Degree9 yrs expEnglish

Job Description

• Provide QA oversight and support business and CSV activities throughout the lifecycle of GxP computerized systems. • Review and approve CSV deliverables, IT change management requests, and quality records (e.g., NCRs CAPAs) to ensure adherence to 4DMT’s internal procedures and policies, and applicable regulatory requirements and standards. • Review plans and provide day-to-day QA guidance and support to initial validation, steady state activities and controlled change-related initiatives of GxP systems. • Serve as a subject matter expert (SME) in CSV requirements, data integrity controls, and related regulatory requirements / standards, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH Guidelines. • Develop and/or refine QA and CSV-related procedures and templates. • Support audits for qualification and requalification of IT vendors. • Collaborate across functions and within Quality to identify areas of improvement and implement enhancements. • Support inspection readiness initiatives, audits and regulatory inspections. • Other duties as assigned.

Job Requirements

  • Bachelor’s degree in life sciences, business or related field.
  • 9+ years of experience within the biopharmaceutical industry, preferable in both large and small company environments.
  • 6+ years’ experience in QA CSV.
  • Thorough working knowledge of computer systems validation and computer software assurance.
  • Expertise in 21CFRPart11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practices.
  • Hands-on experience in implementing and maintaining data integrity controls.
  • Experience supporting regulatory inspections and audits.
  • Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation and maintenance.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
  • Excellent written and verbal communication skills; strong interpersonal skills.

Benefits

  • Equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and other protected categories

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