Director, Clinical Quality Assurance
New
O
Oruka TherapeuticsBiotechnology
Remote; Waltham, MA area candidates preferred.Full-TimeDirector
Salary213,000 - 240,000 USD per year
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Job Details
- Experience
- 10+ years
- Required Skills
- GCP
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline.
- 10+ years of experience in Clinical QA/GCP Quality within biotech, pharma, or CRO.
- Strong knowledge of GCP and applicable global clinical regulatory requirements.
- Experience supporting quality oversight for Phase 1–3 clinical trials.
- Demonstrated experience with GCP audits (investigator site and/or vendor).
- Experience supporting clinical deviations, investigations, CAPAs, and quality system activities.
- Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO.
- Strong working knowledge of sponsor oversight expectations for CROs and vendors.
- Willingness to travel (10-15%) for audits, site visits, and inspection activities.
Responsibilities
- Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP and regulatory requirements.
- Manage clinical deviations, investigations, root cause analysis, CAPA development, and change control.
- Conduct and manage investigator site, vendor, study-specific, and for-cause audits.
- Develop and execute a phase-appropriate GCP audit strategy and annual audit program.
- Lead GCP inspection readiness activities and support global regulatory inspections, including FDA BIMO.
- Support qualification, selection, and ongoing oversight of CROs and GCP-relevant vendors.
- Provide quality oversight for TMF health and inspection-ready documentation practices.
- Collaborate with clinical operations and development functions to assess and mitigate quality risks.
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