Manager/Sr. Manager Clinical Quality Assurance - CQA
$150k - $190kScientific Search
Manager/Sr. Manager Clinical Quality Assurance - CQA Salary: $150–190k (flexible depending on experience) Location: Morristown, NJ area – Hybrid Preferred - Remote is possible Therapeutic Area : Oncology and Rare Disease We are partnered with a growing, commercial-stage biotech organization focused on advancing innovative therapies in rare disease areas. This is an opportunity to join a collaborative team supporting clinical development programs while ensuring the highest standards of quality and compliance. This role reports into senior Regulatory leadership and is responsible for ensuring that clinical operations and research activities are conducted in accordance with applicable regulations, including GCP, HIPAA, and other GxP standards. The Manager/Sr. Manager CQA will support the design, implementation, and oversight of quality systems, processes, and training programs that promote compliance across all phases of clinical development, while partnering cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, and external vendors. Responsibilities
- Support the design, implementation, and continuous improvement of clinical quality systems aligned with GCP, HIPAA, ICH E6(R2), and applicable FDA and international regulations
- Conduct routine and for-cause audits of clinical trial sites, vendors, CROs, and internal processes; document findings and track CAPAs to resolution
- Review and approve clinical study documents including protocols, informed consent forms, monitoring plans, and clinical study reports for GCP compliance
- Serve as a subject matter expert for GCP and HIPAA requirements; provide guidance to cross-functional teams on regulatory obligations
- Develop, maintain, and oversee the Learning Management System (LMS) to ensure training curricula are current and audit-ready
- Design, assign, and track GxP training programs for clinical staff, contractors, and site personnel; generate compliance reports and escalate gaps as needed
- Lead preparation for and participate in internal quality audits, regulatory inspections (e.g., FDA, EMA), and third-party vendor qualifications
- Manage and track deviations, protocol deviations, and serious breaches; implement corrective and preventive actions
- Maintain and update SOPs, work instructions, and quality plans for clinical operations
- Partner with Clinical Operations and Data Management teams to ensure data integrity and traceability throughout the clinical trial lifecycle
- Contribute to the development of clinical quality metrics and prepare reports for senior leadership
- Support inspection readiness activities, including mock inspections and training simulations
- Bachelor’s degree in life sciences or related field (advanced degree preferred)
- 3–5 years of experience in clinical quality assurance or GxP compliance within pharma, biotech, or CRO environments
- Strong knowledge of GCP (ICH E6(R2)), FDA regulations, HIPAA, and global clinical trial requirements
- Hands-on experience conducting clinical site and vendor audits and managing CAPA processes
- Experience with clinical quality documentation, SOP development, and inspection readiness
- Familiarity with LMS systems and GxP training programs preferred
- Strong communication skills and ability to work cross-functionally in a fast-paced environment
- Growing biotech with an expanding pipeline
- High-impact role supporting clinical quality and compliance
- Collaborative, cross-functional environment
- Opportunity to contribute to inspection readiness and quality systems development
- Competitive compensation and growth potential
Vacancy posted 3 days ago
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