Associate Director, Quality Systems

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

About Us

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.

The Role

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, and 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.

Key Responsibilities

• Manage the day-to-day operation and administration of the electronic QMS, including users, roles, permissions, workflows, document and record types, metadata, and related system configuration.
• Manage document and records processes, including document lifecycle, classification, retention, archival status, retrieval, and appropriate controls for GxP and company records.
• Partner with functional groups to maintain applicable company policies, procedures, and GxP documents within the document management system.
• Manage onboarding and offboarding activities related to QMS access, training assignments, and other quality system requirements.
• Manage the GxP training program, including role-based training matrices and curricula, training assignments, system administration, follow-up of required training, and evaluation of training effectiveness, and qualification or competency requirements.
• Serve as a subject matter resource for core QMS processes, including 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 assessment of QMS effectiveness.
• Apply ISO 9001 principles to support integration and effective management of applicable company-wide policies and processes within the quality management system.
• Identify and implement opportunities to simplify and improve quality system processes while maintaining appropriate compliance and control.
• Support process improvement, standardization, workflow optimization, continuous improvement, and operational excellence, with increasing responsibility in these areas as the company progresses toward commercialization.
• Support inspection and audit readiness by ensuring quality system documentation, records, and training information are complete, current, organized, and readily retrievable.
• Support computerized system validation activities and, depending on organizational needs and team capabilities, may assume primary responsibility for the computerized system validation program.
• Flex across Quality responsibilities as organizational needs evolve.

Required Experience & Skills

• 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

Preferred Experience & Skills

• 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

Base Salary Range: $170k - $200k

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires.

To learn more about E-Verify please review this poster.