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Senior Manager, R&D QA
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TapTalent.ai 2 days ago Be among the first 25 applicants Join to apply for the
Senior Manager, R&D QA
role at
TapTalent.ai Get AI-powered advice on this job and more exclusive features. 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
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
Qualifications
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
Ready to lead our quality assurance efforts? Apply now and join us on this exciting journey! Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at TapTalent.ai by 2x Get notified about new Senior Research Development Manager jobs in
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Senior Manager, R&D QA
role at
TapTalent.ai 2 days ago Be among the first 25 applicants Join to apply for the
Senior Manager, R&D QA
role at
TapTalent.ai Get AI-powered advice on this job and more exclusive features. 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
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
Qualifications
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
Ready to lead our quality assurance efforts? Apply now and join us on this exciting journey! Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at TapTalent.ai by 2x Get notified about new Senior Research Development Manager jobs in
Cambridge, MA . R&D Manager of Systems - Electrophysiology
Cambridge, MA $103,700.00-$197,000.00 1 week ago Senior Director of Preclinical Research and Development
Director / Scientist of Antibody Research and Development
Boston, MA $200,000.00-$250,000.00 2 weeks ago Director, Project Management & R&D Operations
Marlborough, MA $103,700.00-$197,000.00 1 week ago Boston, MA $180,000.00-$220,000.00 4 months ago Boston, MA $144,660.00-$238,650.00 2 weeks ago Cambridge, MA $185,000.00-$215,000.00 1 month ago Lowell, MA $144,660.00-$238,650.00 2 weeks ago Boston, MA $188,000.00-$282,000.00 4 days ago Cambridge, MA $150,000.00-$160,000.00 1 week ago Engineering Manager, Orders Core Services
Boston, MA $190,000.00-$230,000.00 3 weeks ago Greater Boston $170,000.00-$185,000.00 3 days ago Boston, MA $143,000.00-$216,000.00 6 days ago Senior Director, R&D Data Science and Digital Health, RWE and Advanced Analytics
Cambridge, MA $193,000.00-$333,500.00 5 days ago Cambridge, MA $236,600.00-$439,400.00 1 week ago Director, R&D DSDH RWE & Advanced Analytics
Needham, MA $146,500.00-$169,000.00 5 days ago Senior Director, R&D Data Science & Digital Health - Hematology-Oncology
Cambridge, MA $173,000.00-$299,000.00 4 days ago Sr. Director, R&D Quality and Compliance
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr