Senior Quality & Risk Leader: Compliance Strategy

Brave; San Francisco (CA); Hybrid; USD 225,000 - 290,000; Full time

Benefits offered by this job

Equal opportunity employer

E‑Verify employment poster

Remote/Hybrid options

Job summary

Braveheart Bio is seeking a Senior Director of Quality Compliance and Risk Management to lead GxP quality programs and ensure inspection readiness in late-stage development. You will partner with Regulatory, IT, and Clinical teams to assess risks and drive corrective actions across GMP, GCP, and GLP activities.

The role requires deep expertise in data integrity, vendor oversight, and internal/external audit leadership, with strong communication and strategic decision-making skills.

Qualifications

• Bachelor’s degree in life science, quality, engineering, or related field.
• 15+ years of progressive pharmaceutical/biotech Quality experience.
• Broad GxP expertise across GMP, GCP, GLP, data integrity and more.

Responsibilities

• Maintain inspection readiness and manage gap assessments and mock inspections.
• Lead data integrity assessments and quality risk analyses across GxP activities.
• Own vendor qualification and external audit programs with oversight of findings.

Skills

Quality compliance

Quality risk management

GxP auditing

Inspection readiness

Data integrity

Vendor oversight

Regulatory inspections

Cross-functional leadership

Communication skills

Problem solving

Education

Bachelor’s degree in life science, quality, engineering, or related

Job description

Braveheart Bio is seeking a Senior Director of Quality Compliance and Risk Management to lead GxP quality programs and ensure inspection readiness in late-stage development. You will partner with Regulatory, IT, and Clinical teams to assess risks and drive corrective actions across GMP, GCP, and GLP activities.

The role requires deep expertise in data integrity, vendor oversight, and internal/external audit leadership, with strong communication and strategic decision-making skills.