Chief Quality Officer

Job Description

About the Organization

We are a globally integrated, innovation-driven leader in biologics manufacturing, advanced therapeutics, and next-generation pharmaceutical platforms, delivering life-saving treatments across oncology, rare diseases, immunology, and cell & gene therapy. With a multi-billion-dollar global footprint and operations spanning North America, Europe, and Asia-Pacific, the organization operates highly sophisticated, GMP-regulated manufacturing facilities and R&D ecosystems that support both commercial-scale production and cutting-edge clinical development.

Our capabilities include large-scale biologics production, mRNA platforms, viral vector manufacturing, and precision medicine pipelines, supported by advanced digital quality systems and real-time analytics. We partner with leading global pharmaceutical companies, biotech innovators, and healthcare systems to accelerate the delivery of safe, effective, and compliant therapies to patients worldwide.

Quality is at the core of everything we do, not only as a regulatory requirement but as a strategic differentiator that enables speed, scalability, and trust in highly regulated markets. As we expand our global manufacturing and clinical operations, we are seeking a Chief Quality Officer to lead enterprise-wide quality strategy, ensuring regulatory excellence, product integrity, and continuous improvement across all stages of the product lifecycle.

This role is a critical member of the executive leadership team, responsible for shaping a world-class quality organization capable of operating at scale across complex, multi-site global operations.

Essential Duties and Responsibilities

• Define and execute a global quality strategy aligned with regulatory requirements, product safety, and operational excellence.
• Oversee all quality functions, including Quality Assurance (QA), Quality Control (QC), Validation, and Compliance across global sites.
• Ensure compliance with international regulatory frameworks, including FDA, EMA, MHRA, GMP, GxP, and ICH guidelines.
• Establish and maintain a robust, enterprise-wide Quality Management System (QMS) across manufacturing, R&D, and distribution.
• Lead inspection readiness and serve as the primary executive contact for regulatory agencies, audits, and inspections.
• Oversee deviation management, CAPA processes, change control, and risk management frameworks.
• Drive continuous improvement initiatives focused on process optimization, quality metrics, and defect reduction.
• Implement advanced digital quality systems, data analytics, and real-time monitoring tools.
• Collaborate cross-functionally with R&D, manufacturing, supply chain, and regulatory affairs to ensure quality alignment across the product lifecycle.
• Lead global quality teams, ensuring consistent standards across multi-site, multi-region operations.
• Provide executive oversight on product release, batch certification, and quality-related decision-making.

Job Qualifications and Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree (PhD, PharmD, or MBA) strongly preferred.
• 20+ years of progressive leadership experience in pharmaceutical, biologics, or advanced therapeutics quality environments.
• Proven experience as a Chief Quality Officer, Head of Quality, or equivalent executive role in a global organization.
• Deep expertise in GMP, GxP, FDA/EMA regulations, and global regulatory compliance frameworks.
• Demonstrated success in managing multi-site global manufacturing quality operations.
• Strong experience with regulatory inspections, including successful outcomes with the FDA, EMA, and other global authorities.
• Experience implementing enterprise QMS systems and digital quality transformation initiatives.
• Strong leadership experience managing large, cross-functional global teams.

Personal Capabilities and Qualifications

• Executive-level leadership with strong regulatory credibility and technical expertise.
• Strategic mindset with the ability to align quality with business performance and operational excellence.
• Exceptional decision-making capability in high-risk, high-compliance environments.
• Strong communication and stakeholder engagement skills, including Board-level interaction.
• High level of integrity, accountability, and commitment to patient safety.
• Ability to lead large-scale organizational transformation and cultural change.
• Resilience and adaptability in complex, fast-evolving regulatory environments.

Strategic Support

• Partner with the CEO and Board to define enterprise quality strategy and governance frameworks.
• Support global expansion initiatives by ensuring quality scalability across new markets and facilities.
• Align quality strategy with R&D innovation, manufacturing scale-up, and commercialization efforts.
• Provide strategic oversight on risk management, compliance, and regulatory engagement.
• Contribute to enterprise-wide initiatives, including digital transformation and operational excellence programs.

Working Conditions

• Fully remote within the United States with global operational oversight.
• Frequent international travel required (25–40%) for site visits, audits, and regulatory interactions.
• High-responsibility executive role in a highly regulated, mission-critical environment.
• Direct engagement with regulatory agencies, executive leadership, and Board stakeholders.

Job Function

The Chief Quality Officer serves as the enterprise authority on quality and compliance, responsible for ensuring that all products, processes, and systems meet the highest standards of safety, efficacy, and regulatory compliance. This role integrates quality strategy, operational execution, and governance into a unified leadership mandate.

Compensation & Benefits

• Compensation Package: $410,000 – $530,000 (base salary)
• Annual executive bonus and performance incentives
• Long-term equity participation (RSUs, stock options, performance shares)
• Comprehensive executive health, wellness, and insurance benefits
• Retirement and wealth planning programs
• Executive-level support resources and professional development

Why Join Us

• Lead quality strategy for a global organization delivering life-saving therapies and advanced medical innovations.
• Operate at the forefront of biologics and next-generation therapeutics manufacturing.
• Partner with executive leadership and regulators on high-impact, mission-critical initiatives.
• Drive enterprise-wide quality transformation at a global scale.
• Make a meaningful impact on patient safety, product integrity, and healthcare outcomes worldwide.