Director, Clinical Quality & Inspection Readiness

Braveheart Bio; San Francisco (CA); Hybrid; USD 200,000 - 290,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits package

Job summary

Braveheart Bio is seeking a Director/Senior Director of Clinical Quality to lead quality oversight for late-stage programs, including global Phase 3 readiness and regulatory interactions. This hands-on leader partners with Clinical Operations, Regulatory, Biometrics, and external CROs to ensure best-in-class quality oversight.

The role requires a deep knowledge of GCP/GxP, GDPR compliance, and a track record in building quality programs within lean biotech environments.

Qualifications

• Bachelor's degree in life sciences, nursing, or related discipline; advanced degree preferred.
• At least 10 years of GCP quality experience, including oversight and late-stage development.
• Strong knowledge of global GxP regulations and regulatory expectations for late-stage programs.
• Experience developing quality oversight strategies, overseeing vendors and CROs, and supporting inspection readiness.
• Experience with GDPR and clinical data privacy compliance.
• Demonstrated experience with computerized system validation for clinical systems in a regulated environment.
• Proven ability to assess risk, solve complex problems, and implement scalable quality solutions.
• Excellent written and verbal communication with a collaborative approach.

Responsibilities

• Lead clinical quality strategy aligned with regulatory requirements and business priorities.
• Provide GCP quality oversight of CROs, vendors, and clinical sites.
• Direct GCP inspection readiness activities and support health authority inspections.
• Develop and maintain clinical quality study oversight plans.

Skills

GCP oversight

Global clinical development

GxP regulations

Regulatory interactions

GDPR compliance

Quality strategy

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Braveheart Bio is seeking a Director/Senior Director of Clinical Quality to lead quality oversight for late-stage programs, including global Phase 3 readiness and regulatory interactions. This hands-on leader partners with Clinical Operations, Regulatory, Biometrics, and external CROs to ensure best-in-class quality oversight.

The role requires a deep knowledge of GCP/GxP, GDPR compliance, and a track record in building quality programs within lean biotech environments.