Serve as a quality leader for Braveheart Bio and will be responsible for manufacturing quality oversight, and inspection readiness for our late-stage clinical program in hypertrophic cardiomyopathy (HCM)
Execute the manufacturing quality oversight framework for investigational and commercial product to support global Phase 3 execution and to prepare for future regulatory submissions and commercialization activities
Partner closely with Manufacturing, Regulatory, partners, and CDMOs to ensure best-in-class quality oversight across all programs
Build a small team as the company grows
Demonstrate end-to-end oversight of outsourced GMP activities across CDMOs, CMOs, and contract laboratories
Monitor vendors and ensure compliance with Quality Agreements
Use risk-based approaches to prioritize oversight activities
Manage the quality transition from clinical to commercial manufacturing
Align GMP systems with regulatory commitments and post-approval requirements
Maintain focus on sustained state of control
Build and sustain a continuous inspection readiness culture
Lead teams through mock inspections and document readiness
Ensure rapid, thorough, and strategic responses to inspection findings
Work closely with CMC teams to embed quality expectations into the product development lifecycle
Participate in project team meetings and cross-functional planning activities to ensure quality considerations are integrated into decision-making
Provide ad hoc quality support across broader GxP activities as business needs evolve
Support quality systems activities as needed
Support enterprise quality system activities as needed
Contribute to cross-functional quality initiatives, inspections, and issue resolution

Requirements

Bachelor’s degree in life sciences or related discipline; advanced degree preferred
12+ years of GxP quality experience in the biotechnology/pharmaceutical industry, including deep experience in GMP and GDP oversight and global product development; GCP, GLP, GVP a plus
Strong knowledge of global GMP regulations and regulatory expectations for late-stage clinical programs and commercialization
Proven success executing manufacturing and supply chain quality oversight in a small or emerging biotech environment, including outsourced and virtual manufacturing models
Experience collaborating with vendors and CDMOs, supporting inspection readiness and regulatory interactions
Demonstrated experience with quality oversight of analytical method validation and process validation (PPQ)
Has deep understanding of global regulatory inspection expectations
Skilled in inspection management and communication (clear, concise, controlled responses)
Demonstrated experience providing hands-on functional leadership, with the ability to set clear direction aligned to corporate strategy, regulatory requirements, and program objectives
Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
Demonstrated experience supporting global Phase 1 through commercial products, including interaction with QPs
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.

Benefits

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GxP quality experienceGMP oversightGDP oversightGCPGLPGVPanalytical method validationprocess validationinspection managementquality systems activities

Soft Skills

leadershipcommunicationproblem-solvingcollaborationadaptabilityteam-orientedrisk assessmentstrategic thinkingflexibilityproactivity