Barrington James
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Barrington James provided pay range This range is provided by Barrington James. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $160,000.00/yr - $185,000.00/yr
Senior Manager, GCP Quality | Full Time | Hybrid | Boston, MA, US
Currently working with one of our closely partnered Biotech focusing in oncology therapies. Fast growing start up with an aim to improve the lives of those fighting cancer.
Actively participating in cross‑functional study teams to ensure GCP/GVP compliance, assisting in identifying and communicating clinical trial‑related risks and opportunities for process improvement. The Senior Manager, GCP will report to the Director GCP Quality.
Key Responsibilities
Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines
Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow‑up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders
Provide a support role during regulatory authority inspections and assist with GxP inspection readiness activities
Oversee quality aspects related to clinical study start‑up, execution, and close‑out by providing leadership, guidance, and direction to staff consistent with GCP/GVP
Support Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls
Skill & Qualifications
Bachelor’s degree in scientific discipline.
8 plus years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
Strong understanding of clinical trials and pharmacovigilance reporting
Strong understanding of FDA, EMA, and ICH Health compliance requirements.
Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.).
Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk‑based audit plans.
Experience using QMS (Veeva systems preferred)
Knowledge and experience in GCP, GVP and preferred GLP
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Science and Research
Referrals increase your chances of interviewing at Barrington James by 2x
Inferred from the description for this job
Medical insurance
Vision insurance
Pension plan
401(k)
Paid paternity leave
Child care support
Paid maternity leave
Get notified about new Quality Assurance Manager jobs in
Boston, MA .
#J-18808-Ljbffr
Barrington James provided pay range This range is provided by Barrington James. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $160,000.00/yr - $185,000.00/yr
Senior Manager, GCP Quality | Full Time | Hybrid | Boston, MA, US
Currently working with one of our closely partnered Biotech focusing in oncology therapies. Fast growing start up with an aim to improve the lives of those fighting cancer.
Actively participating in cross‑functional study teams to ensure GCP/GVP compliance, assisting in identifying and communicating clinical trial‑related risks and opportunities for process improvement. The Senior Manager, GCP will report to the Director GCP Quality.
Key Responsibilities
Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines
Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow‑up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders
Provide a support role during regulatory authority inspections and assist with GxP inspection readiness activities
Oversee quality aspects related to clinical study start‑up, execution, and close‑out by providing leadership, guidance, and direction to staff consistent with GCP/GVP
Support Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls
Skill & Qualifications
Bachelor’s degree in scientific discipline.
8 plus years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
Strong understanding of clinical trials and pharmacovigilance reporting
Strong understanding of FDA, EMA, and ICH Health compliance requirements.
Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.).
Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk‑based audit plans.
Experience using QMS (Veeva systems preferred)
Knowledge and experience in GCP, GVP and preferred GLP
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Science and Research
Referrals increase your chances of interviewing at Barrington James by 2x
Inferred from the description for this job
Medical insurance
Vision insurance
Pension plan
401(k)
Paid paternity leave
Child care support
Paid maternity leave
Get notified about new Quality Assurance Manager jobs in
Boston, MA .
#J-18808-Ljbffr