Senior Manager, Clinical Quality Assurance (CQA)

🌟 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.

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

Plan.

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.

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 :

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

clinical research experience.

in GCP and clinical trial that support pharmaceutical development.

inspection experience.

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