Job Description

About the Organization

We are a U.S.-based biotechnology and advanced pharmaceutical manufacturing enterprise focused on next-generation biologics, gene therapies, precision medicine platforms, and complex injectable therapeutics. Our organization operates GMP-certified facilities nationwide and partners with global research institutions and healthcare systems to deliver high-impact therapeutic solutions.

Operating in one of the most regulated industries in the world, our manufacturing and quality systems must meet FDA, EMA, and global regulatory standards while supporting innovation velocity and large-scale production.

As our clinical pipeline expands and commercial manufacturing capacity scales, quality governance, compliance integrity, and operational excellence are central to patient safety and enterprise credibility.

We are seeking a strategic Director of Quality Assurance to lead enterprise-wide QA systems, regulatory compliance oversight, manufacturing quality governance, and continuous improvement initiatives, fully remote within the United States.

This is not a plant-level QA oversight role. This is a national quality systems leadership mandate.

Job Function

The Director of Quality Assurance will oversee enterprise quality management systems (QMS), regulatory inspection readiness, GMP compliance governance, supplier quality alignment, validation frameworks, and risk mitigation processes across distributed manufacturing operations.

This leader ensures product integrity, regulatory alignment, and continuous operational excellence at scale.

Essential Duties and Responsibilities

• Lead enterprise-wide Quality Management System (QMS) governance

• Oversee GMP compliance across distributed manufacturing sites

• Guide FDA and global regulatory inspection readiness initiatives

• Develop and implement quality risk management frameworks

• Oversee deviation management, CAPA processes, and audit programs

• Align quality assurance with manufacturing scale-up initiatives

• Manage supplier quality oversight and third-party vendor compliance

• Strengthen validation protocols for equipment, systems, and processes

• Establish quality KPIs aligned with operational performance goals

• Oversee document control systems and compliance reporting standards

• Present quality performance and risk posture updates to executive leadership

• Lead distributed QA leadership teams nationwide

Strategic Support

• Advise COO and CSO on regulatory risk exposure and compliance strategy

• Support commercialization readiness for new therapeutic launches

• Contribute to M&A due diligence regarding manufacturing quality systems

• Align QA frameworks with long-term manufacturing expansion strategy

• Strengthen ESG and governance reporting related to product safety

• Guide digital transformation initiatives within quality management systems

Job Qualifications and Requirements

• 12–18+ years of progressive quality assurance leadership experience

• 6+ years within biotechnology, pharmaceutical manufacturing, or regulated life sciences industries

• Deep expertise in GMP, FDA regulatory frameworks, and inspection readiness

• Proven experience overseeing multi-site quality governance

• Strong knowledge of validation, CAPA, and quality risk management methodologies

• Experience managing cross-functional compliance teams

• Demonstrated success leading regulatory audits and inspections

• Bachelor’s degree required; advanced degree in Life Sciences preferred

Personal Capabilities and Qualifications

• Strategic and disciplined quality governance mindset

• Executive-level communication capability

• High ethical standards and patient safety orientation

• Strong analytical and risk mitigation capability

• Resilience in high-scrutiny regulatory environments

• Collaborative cross-functional leadership approach

• Strong documentation and compliance with attention to detail

• Ability to lead distributed remote teams effectively

Working Conditions

• Fully Remote – United States

• Periodic domestic travel to manufacturing facilities and regulatory inspections (20–30%)

• High-accountability role tied to regulatory compliance and product quality KPIs

• Collaboration across distributed manufacturing and scientific teams

• Fast-paced, regulated healthcare environment

Compensation & Benefits

Total Compensation Package: $280,000 – $358,000 USD

Compensation Includes:

• Competitive base salary within stated range

• Performance-based annual incentive aligned with compliance and quality metrics

• Long-term incentive participation

• Comprehensive health, dental, and vision coverage

• 401(k) with employer contribution

• Remote work flexibility and home office support

• Professional development and regulatory certification support

• Generous PTO and paid holidays

Why Join Us

• Lead national quality governance within a cutting-edge biotechnology enterprise

• Influence manufacturing excellence supporting life-saving therapies

• Partner with executive and scientific leadership, shaping medical innovation

• Competitive compensation aligned with regulatory responsibility

• Opportunity to build scalable, inspection-ready quality systems in a high-impact industry