Senior Manager, CGP Compliance & Issue Management (Biotech)

TL;DR

Senior Manager, CGP Compliance & Issue Management (Biotech): Leading quality assurance and compliance activities for clinical trials with an accent on investigations, root cause analysis, and CAPA development. Focus on leveraging data trending to identify patterns and driving continuous improvement in GCP standards.

Location: Hybrid (Boston, MA). Candidates can choose to work remotely up to two days per week or on-site five days per week.

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Lead GCP quality oversight, conducting spot checks and data trending to identify emerging risks.
• Oversee internal and external quality events, including investigations, root cause analysis, and effectiveness checks.
• Develop and monitor Corrective and Preventive Actions (CAPAs) to resolve identified issues.
• Generate metrics, KPIs, and dashboards to report on quality trends and compliance performance.
• Mentor and educate stakeholders on best practices for conducting effective root cause investigations.
• Support inspection readiness and provide ongoing training to team members on quality standards.

Requirements

• Bachelor’s Degree and 6+ years of relevant work experience.
• Proven experience leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Strong analytical skills to evaluate complex data sets and derive actionable insights.
• Deep knowledge of current industry trends and GCP (Good Clinical Practice) compliance.
• Strong communication, problem-solving, and critical thinking skills.

Nice to have

• Experience with quality management applications such as Veeva.

Culture & Benefits

• Hybrid work flexibility (up to 2 days remote per week).
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Financial perks including 401(k), student loan repayment programs, and matching charitable donations.
• Commuting subsidy and educational assistance programs.