Tap Growth ai
Senior Manager, Clinical Quality Assurance (CQA)
Tap Growth ai, Cambridge, Massachusetts, us, 02140
Senior Manager, Clinical Quality Assurance (CQA)
Tap Growth ai is seeking a Senior Manager, Clinical Quality Assurance (CQA) to lead quality assurance activities for clinical studies in Cambridge, MA. This full‑time role works from the office and offers a competitive salary range of $166,400 – $208,000, dependent on experience.
Responsibilities
Develop and execute study audit plans, support investigators, manage audit agendas, audit reports, and CAPAs for managed audits and oversee CRO activities. Co‑audit and lead ISAs as needed.
Lead quality activities for Phase 2 and Phase 3 trials, including endpoint de‑risking to identify, manage and report key study risks.
Provide PL oversight of assigned clinical studies as guided by the PL Plan, conducting risk‑based reviews of key study documents against the PL Plan.
Assess EA clinical trial activity and outputs in compliance with protocol, ICH‑GCP, health authority guidance and regulations, procedural documents and best practices.
Execute Quality Event QA roles for study‑specific compliance issues, including sponsor non‑compliance, clinical site non‑compliance, and vendor non‑compliance through guidance on investigations, root‑cause analyses, impact assessments and corrective and preventive action plans.
Qualifications
Bachelor’s degree in life science, technology, biological science, pharmacy, or other health‑related discipline, or equivalent clinical research experience.
Master’s degree in a science, technology, or industry‑related discipline (preferred).
Seven years’ experience in GCP Quality Assurance or similar experience working in GCP and clinical trials that support pharmaceutical development.
Experience overseeing late‑phase clinical trials.
Experience supporting and leading inspection readiness efforts and direct inspection experience.
Compensation & Benefits Salary: $166,400 – $208,000 dependent on experience.
Work Mode: Work From Office.
Employment Type Full‑time.
Seniority Level Mid‑Senior level.
Location Cambridge, MA, United States.
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Responsibilities
Develop and execute study audit plans, support investigators, manage audit agendas, audit reports, and CAPAs for managed audits and oversee CRO activities. Co‑audit and lead ISAs as needed.
Lead quality activities for Phase 2 and Phase 3 trials, including endpoint de‑risking to identify, manage and report key study risks.
Provide PL oversight of assigned clinical studies as guided by the PL Plan, conducting risk‑based reviews of key study documents against the PL Plan.
Assess EA clinical trial activity and outputs in compliance with protocol, ICH‑GCP, health authority guidance and regulations, procedural documents and best practices.
Execute Quality Event QA roles for study‑specific compliance issues, including sponsor non‑compliance, clinical site non‑compliance, and vendor non‑compliance through guidance on investigations, root‑cause analyses, impact assessments and corrective and preventive action plans.
Qualifications
Bachelor’s degree in life science, technology, biological science, pharmacy, or other health‑related discipline, or equivalent clinical research experience.
Master’s degree in a science, technology, or industry‑related discipline (preferred).
Seven years’ experience in GCP Quality Assurance or similar experience working in GCP and clinical trials that support pharmaceutical development.
Experience overseeing late‑phase clinical trials.
Experience supporting and leading inspection readiness efforts and direct inspection experience.
Compensation & Benefits Salary: $166,400 – $208,000 dependent on experience.
Work Mode: Work From Office.
Employment Type Full‑time.
Seniority Level Mid‑Senior level.
Location Cambridge, MA, United States.
#J-18808-Ljbffr