Senior Director, GCP QA & Inspection Readiness

BioSpace; Boston (MA); Hybrid; USD 266,000 - 344,000; Full time

Benefits offered by this job

Hybrid schedule

Annual bonus

Long-term incentive

Job summary

Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to provide strategic leadership and operational oversight for GCP QA across clinical development programs. You will partner with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure trials meet global GCP standards and inspection readiness.

The role emphasizes senior QA leadership, risk-based quality management, and vendor governance, with potential travel as needed.

Qualifications

• 12+ years of progressive GCP QA or Clinical Quality experience.
• Director level or equivalent leadership experience.
• Experience overseeing CROs, vendors, and investigator sites.

Responsibilities

• Define and mature the GCP QA strategy aligned with clinical development.
• Serve as senior GCP QA partner to Clinical Ops and cross-functional teams.
• Lead vendor qualification, audits, and CAPA oversight.
• Oversee GCP SOPs, policies, and training materials.
• Coordinate inspection readiness activities and responses to regulators.

Skills

GCP QA

Clinical Quality

Leadership

Audit & Inspections

CRO Oversight

Inspection Readiness

Education

Bachelor’s degree in science or related field

Tools

eTMF

Veeva

GxP systems

Job description

Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to provide strategic leadership and operational oversight for GCP QA across clinical development programs. You will partner with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure trials meet global GCP standards and inspection readiness.

The role emphasizes senior QA leadership, risk-based quality management, and vendor governance, with potential travel as needed.