Senior Manager, R&D QA
TapTalent.ai
Date: 3 weeks ago
City: Cambridge, MA
Contract type: Full time
We Are Hiring: Senior Manager, R&D Quality Assurance!
Location: Cambridge, MA
Pay Rate: $95.00 - $100.00/hour
The Sr. Manager, Research and Development (R&D) Quality Assurance will independently perform the duties of the QA Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies, ensuring the conduct and compliance of clinical trials in alignment with the Protocol, International and Local Regulations. The Snr. Manager will Lead inspection readiness for assigned studies and lead/support audit activities as required.
Key Responsibilities
Location: Cambridge, MA
Pay Rate: $95.00 - $100.00/hour
The Sr. Manager, Research and Development (R&D) Quality Assurance will independently perform the duties of the QA Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies, ensuring the conduct and compliance of clinical trials in alignment with the Protocol, International and Local Regulations. The Snr. Manager will Lead inspection readiness for assigned studies and lead/support audit activities as required.
Key Responsibilities
- Independently perform the QA Program Lead (PL) role for assigned clinical studies
- Lead and execute study-specific audit plans including:
- Investigator Site Audit (ISA) selection
- Audit agenda and report creation
- CAPA (Corrective and Preventive Action) development
- Oversight or execution of CRO-managed ISAs
- Lead quality activities for Phase 2 & 3 trials focusing on endpoint de-risking and risk identification
- Provide risk-based review of key study documents for compliance with:
- Study Protocol
- ICH-GCP
- Health Authority guidelines
- Company SOPs and best practices
- Conduct oversight of EA (Expertise Area) activities to ensure output compliance
- Act as lead for Quality Events involving:
- Sponsor, site, or vendor non-compliance
- Investigations and root cause analysis
- Impact assessments
- Development and guidance of CAPAs
- Education:
- Bachelor’s degree in life sciences (e.g., technology, biological sciences, pharmacy, or health-related field) or equivalent clinical research experience
- Master’s degree in a science, technology, or industry-related discipline preferred
- Experience:
- Minimum of 7 years of experience in GCP Quality Assurance or relevant clinical trial roles supporting pharmaceutical development
- Proven experience overseeing late-phase clinical trials
- Experience in leading audits
- Experience in inspection readiness and direct participation in inspections
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