Quality Systems Leader, ISO 9001 & GxP

Brave; San Francisco (CA); Hybrid; USD 170,000 - 200,000; Full time

Benefits offered by this job

Competitive compensation

Equity

Benefits package

Job summary

Braveheart Bio is a clinical-stage biopharmaceutical company advancing therapies for HCM. The Associate Director, Quality Systems will lead the QMS, ensure GxP document control, and drive training and compliance across departments.

Reporting to the VP of Quality, this role will help prepare for inspections, manage CAPA and deviation processes, and continually improve quality systems as Braveheart progresses toward commercialization. A strong GMP background is essential.

Qualifications

• Bachelor's degree in life science, quality, engineering, or related discipline.
• Minimum of 10 years of progressive pharmaceutical/biotech quality experience with QMS management.
• Hands-on experience with electronic QMS administration and core QMS processes.
• Knowledge of ISO 9001 principles and QMS requirements.
• Experience developing and maintaining training matrices for GxP.
• Strong GMP understanding for documentation across development.

Responsibilities

• Manage day-to-day operation and administration of the electronic QMS.
• Oversee document lifecycle, retention, and controls for GxP records.
• Partner with functions to maintain policies and GxP documents.
• Handle onboarding/offboarding for QMS access and training.
• Manage GxP training program, matrices, and effectiveness evaluation.
• Serve as SME for QMS processes: document mgmt, change control, deviations, CAPA, training.
• Develop and maintain QMS metrics and reporting for management reviews.
• Apply ISO 9001 principles to company-wide policies within QMS.
• Identify opportunities to simplify quality processes while maintaining compliance.
• Support process improvement and operational excellence initiatives.
• Assist in inspection/audit readiness and computerised system validation.

Skills

QMS administration

Document management

GxP training

Change control

CAPA

ISO 9001

Training matrices

GxP records management

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree in life science or related

Job description

Braveheart Bio is a clinical-stage biopharmaceutical company advancing therapies for HCM. The Associate Director, Quality Systems will lead the QMS, ensure GxP document control, and drive training and compliance across departments.

Reporting to the VP of Quality, this role will help prepare for inspections, manage CAPA and deviation processes, and continually improve quality systems as Braveheart progresses toward commercialization. A strong GMP background is essential.