Senior Director, Quality, Compliance & GxP Risk

Braveheart Bio; San Francisco (CA); On-site; USD 225,000 - 290,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits package

Job summary

Braveheart Bio seeks a Senior Director of Quality Compliance & Risk Management to lead quality compliance, risk assessment, and vendor oversight as the company advances late-stage development. You will work across Quality, Clinical Development, Operations, and IT, guiding data integrity, inspections, and regulatory readiness.

You will shape risk-based quality programs, oversee external audits, and partner with senior leadership to manage complex GxP issues in a fast-paced biotech setting.

Qualifications

• Bachelor’s degree in life science, quality, engineering, or related discipline.
• 15+ years of progressive pharmaceutical/biotech Quality experience.
• Broad GxP disciplines knowledge including GMP, GCP, GLP/nonclinical, data integrity, and computerized systems.

Responsibilities

• Evaluate acceptability of foreign clinical data.
• Maintain inspection readiness with gap assessments and mock inspections.
• Manage vendor qualification, oversight, and audit programs.
• Oversee internal quality audit program and risk-based planning.
• Lead regulatory authority inspections and post-inspection follow-up.
• Monitor regulatory developments and evolving GxP expectations.

Skills

GxP compliance

Quality Risk Management

Vendor oversight

Inspection readiness

Data integrity

Regulatory inspections

GxP auditing

Cross-functional leadership

Risk assessment

Communications

Education

Bachelor's in life science/related

Job description

Braveheart Bio seeks a Senior Director of Quality Compliance & Risk Management to lead quality compliance, risk assessment, and vendor oversight as the company advances late-stage development. You will work across Quality, Clinical Development, Operations, and IT, guiding data integrity, inspections, and regulatory readiness.

You will shape risk-based quality programs, oversee external audits, and partner with senior leadership to manage complex GxP issues in a fast-paced biotech setting.