GCP Operational Quality Senior Manager (Biotech)

TL;DR

GCP Operational Quality Senior Manager (Biotech): Leading quality assurance oversight for clinical trial programs with an accent on GCP compliance, risk-based auditing, CAPA management, and inspection readiness. Focus on investigating quality issues, developing corrective and preventive actions, analyzing compliance metrics, and supporting the protection of clinical trial subjects and data integrity.

Location: Boston, Massachusetts, United States. Hybrid-eligible work allows remote work up to two days per week; an on-site schedule of five days per week is also available. Up to 10% travel may be required.

Salary: $137,800–$206,800 base salary, plus potential annual bonus and equity awards.

Company

hirify.global is a global biotechnology company focused on scientific innovation.

What you will do

• Serve as the GCP Quality Lead for assigned clinical programs and provide compliance interpretation, consultation, and quality support.
• Develop and execute risk-based study audit plans, review audit reports, and oversee responses and CAPA plans.
• Lead domestic and international clinical investigator audits and support regulatory agency inspections.
• Manage quality issue investigations, root cause analysis, CAPA development, and effectiveness checks.
• Review protocols, identify operational risks, and collaborate with study teams on mitigation strategies.
• Analyze quality and compliance KPIs, support inspection readiness, and contribute to continuous improvement and vendor quality initiatives.

Requirements

• Bachelor’s degree in a scientific or allied health discipline.
• Typically 6 years of relevant experience or an equivalent combination of education and experience.
• In-depth knowledge of ICH GCP R2 and global clinical development regulations, including FDA, EU, and MHRA requirements.
• Strong experience across clinical trial development phases involving drugs, biologics, devices, and drug/device combinations.
• Experience with event management, investigations, root cause analysis, CAPA development, and effectiveness checks.
• Ability to manage complex projects, analyze quality metrics, communicate clearly, and work independently.

Culture & Benefits

• Hybrid or on-site work design with flexibility governed by the Flex @ Vertex program.
• Medical, dental, and vision benefits with resources supporting financial, family, and personal wellbeing.
• Generous paid time off, including summer and winter company shutdowns.
• Educational assistance, student loan repayment support, commuting subsidy, matching charitable donations, and 401(k).
• Inclusive workplace with equal employment opportunity and reasonable accommodation support.