Senior Director, Quality Compliance and Risk Management

Senior Director, Quality Compliance And Risk Management

San Francisco, CA or Remote or Hybrid

About Us:

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart's goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.

With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.

The Role:

The Senior Director, Quality Compliance & Risk Management reports to the Vice President of Quality and provides senior-level leadership for quality compliance, Quality risk management, vendor qualification and oversight, internal and external vendor audit programs, inspection readiness and management, data integrity, and related compliance activities. This individual will work closely with Quality, Clinical Development and Operations, CMC, Regulatory Affairs, Pharmacovigilance, IT, Legal/Data Protection, and other functional teams, as well as external CROs, CMOs, laboratories, consultants, technology providers, and other GxP vendors.

The role requires broad GxP expertise, strong independent judgment, and the ability to identify, evaluate, and manage complex or emerging Quality risks as the company progresses through late-stage development and commercialization.

Key Responsibilities:

• Maintain organizational inspection readiness through ongoing GxP gap assessments, readiness reviews, mock inspections, document and process readiness activities, and tracking of significant gaps and mitigation activities.
• Perform and coordinate data integrity assessments, compliance gap analyses, and quality risk assessments across GxP activities, including evaluation of in-licensed programs and data packages; work with appropriate subject matter experts to characterize risks and develop appropriate mitigation strategies.
• Own the GxP vendor qualification and oversight program, including vendor risk classification, initial qualification, periodic evaluation, re-evaluation, continued qualification, ongoing compliance and performance monitoring, and maintenance of appropriate oversight documentation. Develop and coordinate the risk-based external audit program and global audit calendar, including identification and coordination of qualified internal or external auditors and oversight of significant findings, responses, and corrective actions.
• Develop and execute the internal quality audit program, including risk-based planning, execution, reporting, and follow-up.
• Manage regulatory authority inspections when they occur, including inspection planning, front-room/back-room activities, document requests, subject matter expert preparation, inspector interactions, response development, post-inspection follow-up, and tracking of inspection commitments through closure.
• Establish and maintain practical quality risk management approaches for significant compliance issues and ensure material or systemic risks are appropriately evaluated, documented, communicated, and escalated.
• Provide quality oversight of significant data integrity concerns and collaborate with IT, Legal, and the Data Protection Officer in assessing and managing data breaches or privacy events that may affect GxP systems, data, records, product quality, patient safety, or regulatory compliance.
• Provide Quality oversight of GxP computerized systems and computerized system validation activities and, depending on organizational needs and team capabilities, may assume responsibility for the computerized system validation program.
• Monitor relevant regulatory developments, inspection trends, enforcement activity, and…