Director, Clinical Quality Assurance (CQA)
Immunovant
14 hours ago
Remote
United States
Clinical Research and Development
The Role:
Immunovant is seeking a Director, Clinical Quality Assurance (CQA) to lead GCP quality activities for one or more clinical programs and trials (Phase 1–4, including non-interventional studies). Report to the Sr. Director, Clinical Quality Assurance; remote-based.
Key Responsibilities:
- Author, maintain, and implement study-specific Clinical Quality Audit Plan(s) for assigned programs and trials.
- Serve as cross-functional Quality point-of-contact; provide GCP compliance guidance to internal departments.
- Identify, mitigate, or escalate clinical quality risks across clinical development phases.
- Drive proactive quality management via oversight activities related to vendor management and study conduct.
- Author and/or review QMS controlled documents (e.g., SOPs) in line with applicable regulatory requirements (ICH E6, FDA, EMA, MHRA, local regulations).
- Oversee timely Deviation and Investigation management.
- Participate in risk review meetings and review study Risk Management.
- Conduct QA reviews of essential documents (e.g., protocols, study plans/manuals, investigator brochures) for quality, accuracy, and completeness.
- Manage GCP quality issues, CAPAs, and change controls with internal/external stakeholders.
- Identify process improvements to build compliance into clinical activity design and conduct.
- Support Inspection Readiness/Management for competent authority inspections (sponsors, clinical sites, vendors).
Requirements:
- Bachelor’s degree in STEM and/or allied medical field (Nursing, Pharmacy, etc.).
- 7+ years in GCP QA/Quality Management/Clinical Compliance for Phase 1–4 trials (non-interventional included); immunology trial experience strongly preferred.
- Strong knowledge of global GxP regulations (S. FDA/EU and ICH).
- Experience with competent authority inspections (e.g., US FDA GCP BIMO; PAIs).
- Progressive leadership experience.
- Knowledge of how Quality functions and key business areas interrelate.
Work Environment:
- Domestic and international travel up to 25%.
Immunovant is seeking a Director, Clinical Quality Assurance (CQA) to lead GCP quality activities for one or more clinical programs and trials (Phase 1–4, including non-interventional studies). Report to the Sr. Director, Clinical Quality Assurance; remote-based.
Key Responsibilities:
- Author, maintain, and implement study-specific Clinical Quality Audit Plan(s) for assigned programs and trials.
- Serve as cross-functional Quality point-of-contact; provide GCP compliance guidance to internal departments.
- Identify, mitigate, or escalate clinical quality risks across clinical development phases.
- Drive proactive quality management via oversight activities related to vendor management and study conduct.
- Author and/or review QMS controlled documents (e.g., SOPs) in line with applicable regulatory requirements (ICH E6, FDA, EMA, MHRA, local regulations).
- Oversee timely Deviation and Investigation management.
- Participate in risk review meetings and review study Risk Management.
- Conduct QA reviews of essential documents (e.g., protocols, study plans/manuals, investigator brochures) for quality, accuracy, and completeness.
- Manage GCP quality issues, CAPAs, and change controls with internal/external stakeholders.
- Identify process improvements to build compliance into clinical activity design and conduct.
- Support Inspection Readiness/Management for competent authority inspections (sponsors, clinical sites, vendors).
Requirements:
- Bachelor’s degree in STEM and/or allied medical field (Nursing, Pharmacy, etc.).
- 7+ years in GCP QA/Quality Management/Clinical Compliance for Phase 1–4 trials (non-interventional included); immunology trial experience strongly preferred.
- Strong knowledge of global GxP regulations (S. FDA/EU and ICH).
- Experience with competent authority inspections (e.g., US FDA GCP BIMO; PAIs).
- Progressive leadership experience.
- Knowledge of how Quality functions and key business areas interrelate.
Work Environment:
- Domestic and international travel up to 25%.