Senior Manager (Quality Assurance)

🌟 We're Hiring: Senior Manager (Quality Assurance)! 🌟

We are seeking to hire a Senior Manager, R&D Quality Assurance in Cambridge, MA.

📍 Location: Cambridge, United States

⏰ Work Mode: Work From Office

💼 Role: Senior Manager, R&D Quality Assurance

Pay Scale: $166, 400 - $208, 000 (Dependent on Experience)

What You'll Do

• Lead the development and execution of study audit plans, support Investigator
  
  

Sita Audit (ISA) selection, develop audit agendas, audit reports, and CAPAs

(Corrective Action and Preventive Action) for managed audits or oversee CRO

managed ISA activities. Co-audit/lead ISAs, as required.

• For Phase 2 & 3 trials, lead the development and execution of quality activities
  
  

through endpoint de-risking to identify, manage, and report key study risks.

• Develop and execute PL Oversight of assigned clinical studies as guided by the PL
  
  

Plan.

• This includes, but is not limited, to risk-based reviews of key study documents
  
  

against the PL Plan, and assessment of EA clinical trial activity and outputs in

compliance Protocol, ICH-GCP, Health Authority guidance and regulations,

procedural documents and best practices.

• Execute the Quality Event QA roles for study specific compliance issues, including
  
  

sponsor non-compliance, clinical site non-compliance, and vendor non-compliance

through guidance on appropriate investigations, root cause analyses, impact

assessments, and corrective and preventive action plans.

What We're Looking For

• Bachelor’s degree level, preferably life science (technology, biological science,
  
  

pharmacy, or other health related discipline preferred) or equivalent qualification or

clinical research experience.

• Master’s degree in a science, technology, or industry related discipline, preferred.
• Seven years’ experience in GCP Quality Assurance, or similar experience working
  
  

in GCP and clinical trial that support pharmaceutical development.

• Experience in Overseeing late phase clinical trials.
• Experience supporting and leading inspections readiness efforts and direct
  
  

inspection experience.

Ready to make an impact? 🚀 Apply now and let's grow together!