GCP QA Senior Director: Strategy, Inspections & Compliance

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

Benefits offered by this job

Hybrid on-site Tue/Wed

Competitive benefits

Job summary

Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to lead strategic and operational GCP QA across clinical development programs. The role ensures trials meet regulatory requirements, company policies, and global GCP standards while maintaining inspection readiness.

As a senior QA partner to Clinical Operations, Regulatory Affairs, and external service providers, you will shape risk-based quality systems, vendor oversight, and CAPA programs to embed quality by design

Qualifications

• Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 12+ years of progressive GCP Quality Assurance or Clinical Quality experience within biotech/pharma/CRO environments with leadership at Director level.
• Minimum 3 years of people management preferred.
• Deep knowledge of global GCP requirements (ICH E6, FDA, EU CTReg) and inspection readiness.
• Experience with eTMF, clinical quality systems, and electronic GxP; familiarity with 21 CFR Part 11 and data integrity; Veeva or similar platforms preferred.
• Demonstrated experience leading GCP audits and regulatory inspections.
• Experience overseeing CROs, vendors, investigator sites, and other GCP service providers.
• Travel 20%+ as needed.

Responsibilities

• Define, implement, and mature the GCP QA strategy aligned with development objectives and regulatory expectations.
• Serve as senior GCP QA partner to Clinical Operations and cross-functional stakeholders.
• Champion a culture of quality, compliance, patient safety, and data integrity.
• Build, lead, and develop GCP QA capability and external QA resources.
• Ensure GCP processes are risk-based, phase-appropriate, and scalable for outsourced models.
• Lead oversight of SOPs, policies, and training materials.
• Oversee GCP activities by CROs, sites, vendors and service providers.
• Lead vendor qualification, audit strategy, and governance.
• Coordinate inspection readiness, mock inspections, CAPA planning, and regulatory responses.

Skills

GCP QA leadership

Regulatory inspections

CRO oversight

Clinical QA

Quality management

Leadership

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

eTMF

Veeva Vault

GxP systems

Job description

Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to lead strategic and operational GCP QA across clinical development programs. The role ensures trials meet regulatory requirements, company policies, and global GCP standards while maintaining inspection readiness.

As a senior QA partner to Clinical Operations, Regulatory Affairs, and external service providers, you will shape risk-based quality systems, vendor oversight, and CAPA programs to embed quality by design