Senior R&D QA Program Manager - GCP

North Star Staffing Solutions, Inc.; Cambridge (MA); Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Paid relocation

Job summary

SmartRecruiters, Inc. is seeking a Program Manager for R&D Quality Assurance focused on GCP compliance in MA. The role involves leading audits of sites, vendors, and systems to ensure adherence to FDA/ICH guidelines and company SOPs.

It requires strong QA expertise and the ability to drive corrective actions and regulatory readiness. The position supports collaboration across global teams, with responsibilities spanning training, risk assessment, and process improvement to safeguard trial

Qualifications

• Bachelor's degree required.
• Minimum 7 years of pharmaceutical clinical research or development experience.
• Five (5) years of quality assurance auditing experience preferred with a minimum of 3 years required.

Responsibilities

• Lead domestic and international audits of clinical investigator sites, documents, databases, vendors, and internal systems to ensure regulatory compliance.
• Develop and implement a strategic audit plan for all assigned compounds and ensure reports meet SOPs.
• Provide GCP compliance interpretation, training, and support during regulatory inspections.
• Lead investigations into scientific misconduct or serious GCP breaches and propose corrective actions.
• Mentor staff and drive continuous improvement of QA systems and processes.

Skills

Audit Leadership

GCP Compliance

Quality Assurance

Regulatory Knowledge

Project Management

Education

Bachelor's degree

Tools

QAAD

Job description

SmartRecruiters, Inc. is seeking a Program Manager for R&D Quality Assurance focused on GCP compliance in MA. The role involves leading audits of sites, vendors, and systems to ensure adherence to FDA/ICH guidelines and company SOPs.

It requires strong QA expertise and the ability to drive corrective actions and regulatory readiness. The position supports collaboration across global teams, with responsibilities spanning training, risk assessment, and process improvement to safeguard trial