Senior Quality Systems Lead, GxP & QMS

Braveheart Bio; United States; On-site; USD 120,000 - 165,000; Full time

Job summary

Braveheart Bio is seeking an Associate Director of Quality Systems with expertise in electronic QMS, document control, and GxP training to lead a lean, inspection‑ready quality system. You will partner with Legal, IT, HR, and other functions to drive compliant process improvements.

The role demands hands‑on QMS management, CAPA, deviations, change control, metrics, and regulatory readiness as Braveheart advances toward commercialization.

Qualifications

• Bachelor’s degree required; minimum 10 years in pharmaceutical/biotech quality with substantial QMS experience.
• Hands‑on experience with electronic QMS administration, document/records management, GxP training, change control, deviations, CAPA and QMS processes.
• Strong knowledge of ISO 9001 principles and QMS requirements.

Responsibilities

• Manage day‑to‑day operation and administration of the electronic QMS, including users, roles, permissions, workflows, document and record types, metadata, and configuration.
• Manage document and records processes: lifecycle, classification, retention, archival status, retrieval, and controls for GxP and company records.
• Partner with functional groups to maintain policies, procedures, and GxP documents within the DMS.
• Oversee onboarding/offboarding related to QMS access, training assignments, and other quality system requirements.
• Manage the GxP training program: role‑based matrices, curricula, training assignments, competency evaluation.
• Serve as SME for core QMS: document management, change control, deviations, CAPA, quality risk management, training, records management.
• Develop and maintain QMS metrics and trending; support management review and assessment of QMS effectiveness.
• Apply ISO 9001 principles to integrate policies and processes within the QMS.

Skills

QMS administration

GxP training

Document management

Change control

Deviations

CAPA

ISO 9001 principles

Record management

Training matrices

Regulatory knowledge

Documentation discipline

Cross-functional collaboration

Attention to detail

Communication

Project management

Education

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

Job description

Braveheart Bio is seeking an Associate Director of Quality Systems with expertise in electronic QMS, document control, and GxP training to lead a lean, inspection‑ready quality system. You will partner with Legal, IT, HR, and other functions to drive compliant process improvements.

The role demands hands‑on QMS management, CAPA, deviations, change control, metrics, and regulatory readiness as Braveheart advances toward commercialization.