[Hiring] Associate Director, Quality Systems @Braveheart Bio

Role Description

The Associate Director, Quality Systems reports to the Vice President of Quality and is responsible for the day-to-day management, administration, and continued development of the company’s quality management system, including:

• Electronic QMS administration
• Document and records management
• GxP training
• QMS metrics and trending
• Related quality systems processes

The role will collaborate closely with functional groups, including Legal, IT, HR, and Corporate, to maintain a lean, practical, and inspection-ready management system that supports both GxP requirements and applicable company policies and procedures as the organization progresses toward commercialization.

Qualifications

• 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.
• Demonstrated hands-on experience with electronic QMS administration, document and records management, GxP training, change control, deviations, CAPA, and other core QMS processes.
• Demonstrated knowledge and practical application of ISO 9001 principles and quality management system requirements.
• In-depth understanding of controlled documents and GxP record types, metadata, classification, retention, lifecycle management, and retrieval.
• Demonstrated experience developing and maintaining role-based training matrices and administering GxP training programs.
• Strong working knowledge of GxP principles, with sufficient GMP experience to understand and manage documentation and records across pharmaceutical development.
• Strong attention to detail and demonstrated ability to establish and maintain logical, consistent document, record, metadata, and training structures.
• Excellent 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 with a roll-up-your-sleeves, can-do attitude.

Requirements

• Experience working in a small, growing, or startup pharmaceutical or biotechnology organization.
• Experience developing or expanding a quality management system in a growing organization.
• Experience with QMS metrics, trending, management review, process improvement, continuous improvement, and operational excellence.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience supporting regulatory inspections and GxP audits.
• Experience with computerized system validation and oversight of GxP computerized systems.
• Experience supporting late-stage development and transition toward commercial operations.

Benefits

• Base Salary Range: $170k - $200k
• Eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

Company Description

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.