Associate Director, Quality Systems

🕒 Yesterday

🏄 California – Remote

🏄 California – Remote

💵 $170k - $200k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 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

• Manage the day-to-day operation and administration of the electronic QMS, including users, roles, permissions, workflows, document and record types, metadata, and system configuration • Manage document and records processes, including lifecycle, classification, retention, archival status, retrieval, and controls for GxP and company records • Partner with functional groups to maintain company policies, procedures, and GxP documents within the document management system • Manage onboarding and offboarding activities related to QMS access, training assignments, and quality system requirements • Manage the GxP training program, including role-based training matrices, curricula, assignments, system administration, follow-up, effectiveness evaluation, and qualification or competency requirements • Serve as a subject matter resource for document management, change control, deviations, CAPA, quality risk management, training, and records management • Develop and maintain QMS metrics and trending; compile and report departmental Quality metrics; support management review and QMS effectiveness assessment • Apply ISO 9001 principles to integrate and manage applicable company-wide policies and processes within the QMS • Identify and implement opportunities to simplify and improve quality system processes while maintaining compliance and control • Support process improvement, standardization, workflow optimization, continuous improvement, and operational excellence • Support inspection and audit readiness by maintaining complete, current, organized, and retrievable quality system documentation, records, and training information • Support computerized system validation activities and potentially assume primary responsibility for the computerized system validation program • Flex across Quality responsibilities as organizational needs evolve

🎯 Requirements

• Bachelor’s degree in life science, quality, engineering, or related discipline • Minimum of 10 years of progressive pharmaceutical or biotechnology quality experience, with substantial direct experience managing quality management systems • Hands-on experience with electronic QMS administration, document and records management, GxP training, change control, deviations, CAPA, and other core QMS processes • Knowledge and practical application of ISO 9001 principles and quality management system requirements • Understanding of controlled documents and GxP record types, metadata, classification, retention, lifecycle management, and retrieval • Experience developing and maintaining role-based training matrices and administering GxP training programs • Strong working knowledge of GxP principles and sufficient GMP experience across pharmaceutical development • Strong attention to detail and ability to establish and maintain logical, consistent document, record, metadata, and training structures • Organizational, problem-solving, prioritization, and time-management skills • Ability to independently manage multiple quality systems activities and work effectively across functional teams • 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, and hands-on mindset • Federal E-Verify employment authorization confirmation for new hires

🏖️ Benefits

• Competitive total rewards package • Annual bonus eligibility • Equity eligibility • Comprehensive benefits offering