Clinical QA Manager
Redwood City, CA
Research & Development – Quality Assurance /
Contract /
Hybrid
Adverum is looking for a Clinical QA Manager to join our team in our Redwood City office. This position reports to the Director of Clinical Quality Assurance and will collaborate with cross-functional team members of Adverum. The Clinical QA Manager is responsible for executing and supporting the quality management system and oversight of daily quality assurance activities supporting Clinical research compliance.
This is a 6 month contract with the potential to convert to full-time status.
What you'll do:
- Assure that clinical studies/programs meet internal and regulatory requirements.
- Provide risk-based quality oversight for clinical trial activities.
- Review project timelines to ensure clinical phase-appropriate implementation and timely integration of quality activities.
- Perform quality review of clinical trial documents, including but not limited to Clinical Protocols and amendments, Investigator Brochure, Informed Consent.
- Serve as Clinical Quality Representative supporting internal and external clinical study activities.
- Coordinate activities relevant to potential GCP and clinical trial conduct associated quality issues, including but not limited to deviations, investigations, CAPAs, and change control.
- Escalate quality and compliance issues to QA Management in a timely manner and ensure issues are resolved to closure.
- Assess Quality compliance of all clinical programs, including Clinical Investigator sites, CROs, and clinical trial supporting vendors.
- Conduct GCP audits, monitor and track corrective and preventive actions resulting from audit to closure.
- Perform GCP quality training.
- Perform Quality Assurance review of regulatory document clinical sections.
- Support the development and maintenance of the Quality Management System and procedures to comply with applicable GCP standards and regulations.
- Review and approve Clinical trial procedures.
- Support audits, inspections, and inspection readiness activities.
- Other responsibilities as assigned.
About you:
- BS degree required
- 5-7 years of direct clinical trial experience in Biotechnology, Pharmaceutical or CRO (must have been part of the Quality, Compliance or Regulatory department)
- Extensive working knowledge and understanding of ICH GCP, US FDA, and other relevant regulations; US required, EU desired
- Direct auditing experience (ability to travel approx. 20%)
- Ability to work and communicate effectively in a team environment with great organizational skills that enables risk-based quality management and a culture of quality and open dialogue.
- Possess effective interpersonal, verbal, and listening skills.
- Ability to analyze and reconcile moderate to complex issues independently.
- Must be an individual with proven initiative, demonstrated accountability, and ability to manage multiple priorities in a fast-paced environment with high degree of flexibility.
$65 - $85 an hour
This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data.
