Director – Clinical Quality

This is a fully remote position, open to applicants in California.

📋 Description

• Act as a senior quality leader accountable for overseeing clinical quality and ensuring inspection readiness for the late-stage hypertrophic cardiomyopathy clinical program.

• Develop and implement the clinical oversight framework that supports global Phase 3 operations.

• Lead clinical development teams and prepare the organization for regulatory submissions and commercialization efforts.

• Collaborate with Clinical Operations, Regulatory Affairs, Biometrics, Pharmacovigilance, and external CRO and vendor partners on quality oversight.

• Build and potentially manage a small quality team as the company expands.

• Direct the clinical quality strategy in alignment with global regulatory standards, risk-based quality principles, and business objectives.

• Create suitable quality practices for late-stage development and ensure inspection readiness.

• Serve as the company’s GCP subject matter expert, offering quality guidance throughout clinical development processes.

• Lead risk-based GCP quality oversight of CROs, vendors, clinical laboratories, and clinical sites.

• Oversee GCP inspection readiness initiatives and act as a key quality leader during health authority inspections.

• Assist with the validation of computerized systems for clinical applications, including the oversight of validation activities and examination of validation documentation.

• Develop and sustain clinical quality study oversight plans.

• Formulate inspection readiness strategies in collaboration with Quality Compliance and Risk Management.

• Lead investigations into clinical deviations, conduct root cause analyses, and manage CAPA processes.

• Ensure prompt and effective resolution of quality-related issues.

• Maintain inspection readiness across clinical activities, documentation, and teams.

• Work with Legal on GDPR and data privacy obligations.

• Collaborate with Data Management, IT, Legal, and vendors regarding personal data handling, storage, and transfer.

• Support data protection impact assessments, vendor privacy evaluations, and data processing agreements.

• Provide quality assistance to Clinical Operations, Biometrics, Pharmacovigilance, Medical/Clinical Development, Medical Affairs, Nonclinical, and other departments.

• Participate in project team meetings and cross-functional planning sessions.

• Offer ad hoc quality support across broader GxP activities.

• Contribute to cross-functional quality initiatives, inspections, and issue resolution.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, or a related field; advanced degree is preferred.

• A minimum of 10 years of GCP quality experience, with extensive knowledge in GCP oversight, global clinical development, and late-stage development.

• In-depth understanding of global GxP regulations (GCP, GLP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs.

• Capability to assess risk, resolve complex issues, and implement practical, scalable quality solutions.

• Proven track record in establishing and executing clinical oversight in a small or emerging biotech setting.

• Experience in developing quality oversight strategies, managing vendors and CROs, and facilitating inspection readiness and regulatory interactions.

• Demonstrated expertise in GDPR and clinical data privacy compliance.

• Practical experience with computerized system validation for clinical systems within a regulated environment.

• Strong written and verbal communication skills, with a collaborative and team-oriented approach.

• Ability to excel in a fast-paced, dynamic environment while remaining adaptable to change and uncertainty.

• A flexible, proactive, and hands-on attitude with a willingness to take initiative.

• Experience in rare diseases, cardiovascular, or specialty disease clinical development.

• Familiarity with preparations for significant regulatory submissions (NDA/BLA/MAA).

• Prior experience with data privacy frameworks beyond GDPR (e.g., CCPA).

• Audit certification or quality certification (e.g., ASQ) is preferred.

• Experience with GLP (21 CFR Part 58 and OECD) is a plus.

• Employment authorization is required; Braveheart takes part in the federal E-Verify program to confirm employment eligibility for all new hires.

🏝️ Benefits

• Eligibility for an annual bonus.

• Equity eligibility.

• Comprehensive benefits package.