Director, Quality Assurance – Quality Systems
Angitia Biopharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $210,000 - $230,000 per year
Job Level
About the role
- Provide strategic leadership and hands-on oversight for the GxP Quality Management System, ensuring compliance with FDA, EMA, and ICH guidelines relevant to clinical‑stage activities.
- Own the eQMS and its core modules, including governance, optimization, user support, and coordination with IT, internal stakeholders, and vendors.
- Lead document management processes, ensuring controlled documents (SOPs, policies, forms, work instructions) are current, accurate, and aligned with clinical and CMO/CRO operations.
- Oversee the GxP training program, including role‐based curricula, onboarding, training effectiveness, and system performance within the eQMS.
- Direct the deviation and nonconformance process, ensuring high quality investigations, root cause analysis, and effective corrective and preventive actions.
- Own the CAPA system, ensuring quality issues are captured, assessed, prioritized, and addressed with clear plans and effectiveness checks.
- Manage change control processes for GxP documents, quality systems, and relevant operational changes.
- Establish, monitor, and communicate Quality System KPIs to senior leadership; identify trends and drive proactive improvements.
- Support internal and external audits, regulatory inspections, and inspection readiness activities.
- Collaborate with CMO, CDMO, and CRO partners to ensure alignment and oversight of Quality System expectations, documentation, and compliance.
- Contribute to Quality strategy and governance as the company advances into later‑stage clinical studies and early commercial readiness.
Requirements
- Degree in Chemistry, Biochemistry, Molecular Biology, or related field.
- 10+ years of experience in Quality Assurance within biotech/pharma, with strong preference for experience in both clinical and commercial settings.
- Strong, hands-on leadership and operational experience with GxP Quality Systems in a clinical-stage biotech environment.
- Demonstrated expertise with eQMS platforms including system ownership and module configuration.
- Deep knowledge of FDA, EMA, and ICH regulations and guidance applicable to clinical development, cGMP for external manufacturing, and computerized systems.
- Proven experience managing document control, training, deviation/CAPA, and change control processes.
- Quality Operations experience including deviation and change control Quality Approvals, batch disposition, etc.
- Proven ability to lead cross-functional teams and influence without direct authority.
- Exceptional organizational, communication, and strategic thinking skills.
Benefits
- Medical, dental, and vision coverage for employees and their eligible dependents
- 401(K) Retirement Plan with Company match
- Company paid Long Term Disability Coverage
- Company-paid life Insurance & AD&D Coverage
- Voluntary Life Insurance & AD&D Coverage
- Employee Assistance Program (EAP)
- Company-paid Holidays
- Vacation
- Paid Sick Leave
- Telecommunication Monthly Stipend
- Work-From-Home Equipment Reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxP Quality Management SystemeQMSdocument managementCAPA systemdeviation managementroot cause analysischange controlQuality System KPIsclinical developmentcGMP
Soft Skills
leadershipoperational experiencestrategic thinkingorganizational skillscommunication skillsinfluence without authoritycollaborationtraining effectivenessproblem-solvingtrend identification