Director of Quality Systems & Compliance

Braveheart Bio; Oregon (WI); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Competitive compensation

Bonus eligibility

Equity participation

Benefits package

Job summary

Braveheart Bio seeks an Associate Director of Quality Systems to lead the day-to-day operation and ongoing development of the QMS for a clinical-stage biopharmaceutical company focused on hypertrophic cardiomyopathy.

The role partners with Legal, IT, HR, and Corporate to ensure an inspection-ready system, compliant with GxP and company policies, as Braveheart advances toward commercialization.

Qualifications

• 10+ years of progressive pharmaceutical/biotech quality experience, incl. managing quality systems.
• Hands-on experience with electronic QMS administration, document management, GxP training, change control, deviations, CAPA, and core QMS processes.
• Knowledge of ISO 9001 principles and quality management system requirements.
• Understanding of controlled documents, metadata, retention, lifecycle management, and retrieval.
• Experience developing and maintaining role-based training matrices and GxP training programs.
• Strong GMP experience to manage documentation across pharmaceutical development.
• Attention to detail and ability to maintain logical document/record structures.
• Excellent organizational, problem-solving, communication, and time-management skills.
• Ability to work across teams in a fast-paced environment.

Responsibilities

• Manage day-to-day operation and administration of the electronic QMS.
• Oversee document and records processes, lifecycle, retention, archival status, and controls for GxP records.
• Partner with Legal, IT, HR, and Corporate to maintain policies and GxP documents.
• Coordinate onboarding/offboarding for QMS access and training assignments.
• Manage the GxP training program, matrices, curricula, and evaluations.
• Serve as SME for core QMS processes: document management, change control, deviations, CAPA, and risk management.
• Develop and maintain QMS metrics and support management review of QMS effectiveness.
• Apply ISO 9001 principles to integrate policies and processes within QMS.
• Identify opportunities to simplify and improve quality systems while ensuring compliance.
• Support process improvement, standardization, and operational excellence as the company grows.
• Assist inspection/audit readiness through documentation and records management.
• Support computerized system validation and potentially lead the program.
• Be flexible across Quality responsibilities as needs evolve.

Skills

Quality systems management

GxP training

ISO 9001 knowledge

Document management

CAPA & deviations

Change control

Cross-functional collaboration

Training matrices

Audit readiness

Regulatory compliance

Education

Bachelor’s degree in life science, quality, engineering, or related discipline

Tools

QMS software

Document management system

GxP training platforms

CAPA tracking tools

Job description

Braveheart Bio seeks an Associate Director of Quality Systems to lead the day-to-day operation and ongoing development of the QMS for a clinical-stage biopharmaceutical company focused on hypertrophic cardiomyopathy.

The role partners with Legal, IT, HR, and Corporate to ensure an inspection-ready system, compliant with GxP and company policies, as Braveheart advances toward commercialization.