Senior Director – Quality Compliance and Risk Management

🕒 Yesterday

🏄 California – Remote

🏄 California – Remote

💵 $225k - $290k / year

⏰ Full Time

🟠 Senior

🔒 Insurance

👻 Ghost score 9%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Braveheart Bio

WebsiteLinkedInAll Job Openings

1 - 10 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Braveheart Bio is a clinical-stage biotechnology company focused on transforming the care of hypertrophic cardiomyopathy (HCM) and related conditions. The company is developing investigational therapies that selectively target overactive myosin — a key disease mechanism in HCM — and is advancing a program through global late-stage (Phase 3) clinical development to improve heart performance and patient quality of life.

📋 Description

• Provide 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 • Collaborate with Quality, Clinical Development and Operations, CMC, Regulatory Affairs, Pharmacovigilance, IT, Legal/Data Protection, and other functional teams • Work with external CROs, CMOs, laboratories, consultants, technology providers, and other GxP vendors • Maintain organizational inspection readiness through GxP gap assessments, readiness reviews, mock inspections, document and process readiness, and mitigation tracking • Perform and coordinate data integrity assessments, compliance gap analyses, and quality risk assessments across GxP activities • Own the GxP vendor qualification and oversight program and coordinate risk-based external audits and the global audit calendar • Develop and execute the internal quality audit program • Manage regulatory authority inspections, including planning, front-room/back-room activities, document requests, SME preparation, inspector interactions, responses, and follow-up • Establish and maintain quality risk management approaches for significant compliance issues • Provide quality oversight of data integrity concerns, data breaches, and privacy events affecting GxP systems, records, product quality, patient safety, or regulatory compliance • Provide Quality oversight of GxP computerized systems and computerized system validation activities • Monitor regulatory developments, inspection trends, enforcement activity, and evolving GxP expectations • Provide senior-level quality judgment on complex compliance and risk matters

🎯 Requirements

• Bachelor’s degree in life science, quality, engineering, or related discipline • Minimum of 15 years of progressive pharmaceutical or biotechnology Quality experience • Broad substantive experience across multiple GxP disciplines, including GMP, GCP, GLP/nonclinical, data integrity, and computerized systems • Significant experience in Quality compliance, Quality Risk Management, inspection readiness, GxP auditing, and vendor oversight • Experience performing GxP gap analyses, compliance assessments, data integrity assessments, and risk-based evaluation and mitigation • Experience hosting and managing regulatory authority inspections • Experience developing, conducting, or overseeing risk-based internal and external GxP audit programs • Experience managing risk-based vendor qualification, periodic evaluation, re-evaluation, and continued oversight programs • Ability to apply quality risk management principles to complex issues, systems, vendors, data, and business decisions • Strong independent quality judgment and ability to recognize, prioritize, escalate, and address significant or systemic risks • Ability to rapidly assess complex GxP issues, engage subject matter experts, and drive risk-based decisions • Excellent organizational, problem-solving, prioritization, and time-management skills • Strong written and verbal communication skills with a collaborative, team-oriented approach • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity • Flexible, proactive, hands-on mindset • Preferred: experience in small, rapidly growing, or startup pharmaceutical or biotechnology organizations • Preferred: experience supporting late-stage clinical development, regulatory submissions, and transition to commercial operations • Preferred: experience evaluating in-licensed programs or data packages • Preferred: computerized system validation, IT Quality, data integrity, regulatory intelligence, and broad Quality leadership experience

🏖️ Benefits

• Competitive total rewards package • Annual bonus eligibility • Equity eligibility • Comprehensive benefits offering • Equal opportunity and inclusion commitment • Federal E-Verify employment authorization verification for new hires