Senior Manager, Clinical Quality Assurance (Contract)
About The Position
The Senior Manager, Clinical Quality Assurance is a contract role and an internal expert on applying GCP, ICH, and global regulatory requirements across Kriya’s Quality Management System (QMS). The role owns standards, training, and oversight that help keep clinical trial activities audit-ready. It sets the approach for Clinical SOPs, the DOT eQMS Clinical module, and GCP training, and provides QA oversight of CROs, vendors, and quality events during trial conduct. The role partners with Clinical Operations and other functions to support quality across clinical programs. It provides proactive guidance to study teams, identifies risks, and leads mitigation strategies; supports inspection readiness; and contributes tools, templates, metrics, and continuous improvement initiatives within the QMS. Work may be remote or hybrid, as applicable. It is normally performed at a desk, involves lifting under 20 lbs, and requires occasional travel. The role may require work outside normal business hours to support clinical project team members across different time zones.
Requirements
- Bachelor’s degree in a scientific or related discipline.
- 7–10 years of experience in clinical quality and/or clinical operations in a biotech, pharmaceutical, or CRO environment.
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and global regulatory requirements.
- Experience with Quality Management Systems (QMS) and SOP development.
- Exposure to audits, CAPAs, and inspection readiness activities.
- Ability to work independently and effectively in a collaborative environment.
- Strong problem-solving and critical-thinking skills.
- Excellent communication and interpersonal skills.
- High level of organization and ability to manage multiple priorities.
- Willingness to take on increasing responsibility and ownership.
Nice To Haves
- Advanced degree.
- Experience in gene therapy, biologics, or advanced therapeutics.
Responsibilities
- Review and provide oversight of clinical QA documentation, including SOPs, protocols, informed consent forms, reports, and study-level documents.
- Collaborate with Clinical Operations teams to maintain compliance with GCP, ICH, and internal procedures.
- Perform quality assessments of clinical processes, documentation, and outputs.
- Maintain accurate documentation of quality activities, including deviations, CAPAs, and quality events.
- Define standards for SOP development, revision, and implementation.
- Serve as a QA subject matter expert for assigned clinical studies or programs.
- Provide proactive quality guidance to study teams, identify risks, and lead mitigation strategies.
- Lead audits of CROs, vendors, and investigator sites.
- Oversee vendor qualification and oversight activities.
- Ensure audit findings are tracked and addressed appropriately.
- Own investigations of quality events and deviations.
- Drive root cause analysis and CAPA development.
- Track CAPAs and coordinate timely closure.
- Support inspection readiness activities, including document review, gap assessments, and back-room support.
- Partner with Clinical Operations and other functions to support quality across clinical programs.
- Develop tools, templates, and quality metrics.
- Contribute to continuous improvement initiatives within the QMS.
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What This Job Offers
Career Level
Senior
