Quality, Compliance & Risk Sr. Director

Braveheart Bio; Oregon (WI); On-site; USD 225,000 - 290,000; Full time

Benefits offered by this job

Competitive total rewards package

Equal opportunity employer

Job summary

Braveheart Bio is seeking a Senior Director of Quality Compliance & Risk Management to lead quality compliance, risk management, vendor oversight, and inspection readiness. The role collaborates across Regulatory, IT, Legal, and CRO/CMO partners in a late-stage development setting.

The position requires 15+ years in pharmaceutical/biotech QA, extensive GxP experience, and proven ability to manage complex risk and audit programs.

Qualifications

• Bachelor’s degree in life science, quality, engineering, or related discipline is required.
• Experience across GMP, GCP, GLP/nonclinical and data integrity.
• Strong leadership and ability to manage complex GxP programs.

Responsibilities

• Maintain inspection readiness with ongoing GxP gap assessments and readiness reviews.
• Coordinate data integrity assessments and quality risk analyses across GxP activities.
• Own vendor qualification and oversight, including risk classifications and audits.
• Develop and execute internal quality audit programs with risk-based planning.

Skills

Quality leadership

GxP expertise

Audit management

Regulatory inspections

Data integrity

Vendor oversight

Risk assessment

Communication

Problem solving

Education

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

Job description

Braveheart Bio is seeking a Senior Director of Quality Compliance & Risk Management to lead quality compliance, risk management, vendor oversight, and inspection readiness. The role collaborates across Regulatory, IT, Legal, and CRO/CMO partners in a late-stage development setting.

The position requires 15+ years in pharmaceutical/biotech QA, extensive GxP experience, and proven ability to manage complex risk and audit programs.