4D Molecular Therapeutics

Associate Director, QA Computer System Validation

4D Molecular Therapeutics

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $169,000 - $197,000 per year

Job Level

Senior

About the role

  • 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.

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
computer systems validationcomputer software assurancedata integrity controlsrisk-based approachesGxPquality assuranceauditsregulatory inspections21 CFR Part 11EU Annex 11
Soft Skills
team playercustomer servicesolution orientedattention to detailindependent workinterpersonal skillswritten communicationverbal communicationcollaborationconsulting