Director, Clinical Quality & Compliance Strategy

Quality Search Personal GmbH; Boston (MA); On-site; USD 177,000 - 278,080; Full time

Job summary

JobRx, Inc. in Boston, MA is seeking a Director of Clinical Program Quality to shape and lead risk-based quality management across clinical assets, driving program performance, regulatory confidence, and timely market approvals.

Lead governance forums, manage investigations, and drive inspection readiness while embedding quality by design throughout the trial lifecycle. This role reports to the Head of Clinical Program Quality.

Qualifications

• Bachelor's degree in a scientific or allied health/medical field.
• 10+ years in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development programs.
• Advanced expertise across the clinical development lifecycle with deep knowledge of GCP regulations and guidelines.
• Experience in quality leadership roles, including audit programs and regulatory inspection management.

Responsibilities

• Develop and execute proactive, risk-based quality management strategies across assigned clinical development assets.
• Provide strategic quality leadership by elevating critical quality issues and mitigation plans to governance bodies.
• Lead investigations of Serious Breaches (GCP), scientific misconduct, and other significant quality events with root cause analysis.
• Drive end-to-end inspection readiness across assigned clinical programs and lifecycle.
• Shape and execute global GCP inspection strategies for regulatory interactions.
• Design risk-based audit strategies to identify quality concerns early and mitigate risks.
• Mentor Clinical Program Quality team members and Study Execution Teams.
• Advance continuous improvement across R&D Quality and Pharmacovigilance.

Skills

Quality leadership

GCP regulations knowledge

Regulatory inspections knowledge

Education

BSc required (scientific/medical)

MSc or PhD preferred

Job description

JobRx, Inc. in Boston, MA is seeking a Director of Clinical Program Quality to shape and lead risk-based quality management across clinical assets, driving program performance, regulatory confidence, and timely market approvals.

Lead governance forums, manage investigations, and drive inspection readiness while embedding quality by design throughout the trial lifecycle. This role reports to the Head of Clinical Program Quality.