Job Title:
Manager, Clinical Quality
Company:
Arcellx
Location:
Redwood City, California, USA
Job Type:
Full-time
About Arcellx:
Arcellx is a public, clinical-stage biotechnology company focused on developing innovative cell therapies for cancer and other incurable diseases. With offices in Redwood City, CA, and Gaithersburg, MD, the company fosters a diverse, collaborative, and informal work environment where team members are empowered to do their best work.
Core Values:
Character: Do what’s right, always.
Audacity: Challenge the status quo and share honest feedback.
Determination: Be curious, driven, and growth-oriented.
Collaboration: Embrace teamwork; no job is too small.
Originality: Value diverse perspectives and ideas.
Job Summary:
The Manager, Clinical Quality will lead GCP quality oversight for Phase I–III clinical trials, working closely with clinical and medical affairs to maintain compliance with regulatory requirements. The role will play a vital part in ensuring Arcellx’s quality systems are robust and audit-ready.
Key Responsibilities:
Lead GCP compliance support for clinical trials and ensure alignment with global regulatory standards.
Develop and implement audit plans and strategies for clinical studies.
Conduct audits of clinical vendors, investigative sites, and internal systems.
Report findings and track corrective and preventive actions (CAPAs).
Participate in development and optimization of SOPs, WIs, templates, and forms.
Train staff on GCP, inspection readiness, and quality expectations.
Assist in regulatory inspection preparation and execution.
Provide expert compliance guidance to internal clinical teams.
Required Qualifications:
Bachelor’s degree with 8+ years of GCP experience in pharmaceutical or biologics sectors. Related industries like medical devices or diagnostics considered.
Experience with clinical quality systems in CBER-regulated biotech companies.
Deep understanding of GCP regulations and guidance.
Strong risk assessment, prioritization, and project management skills.
Excellent written and verbal communication.
Willingness to travel up to 20%.
Compensation:
Manager level: $135,000–$155,000
Senior Manager level: $155,000–$180,000
Includes annual bonus based on company performance and equity (RSU) grants.
Relocation assistance available if required.
Benefits:
100% coverage for medical, dental, and vision (team members + dependents)
Unlimited vacation
3-day weekend every month
Fully paid parental leave (up to 6 months)
Tuition reimbursement
401(k) employer contributions
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