Head, Global Quality

The Global Head, Quality is responsible for developing, implementing, and leading the company's global Quality strategy, Quality Management System (QMS), and overall Quality organization across operations at all company sites. This executive leader ensures compliance with applicable global regulatory requirements, industry standards, and company quality objectives while supporting business growth, innovation, and operational excellence.

The role oversees Quality Assurance, Quality Control, Validation, Supplier Quality, Compliance, Audits, Inspection Readiness, and Quality Systems across research, development, manufacturing, distribution, and commercialization activities. The Global Head of Quality serves as a key member of the executive leadership team and acts as the primary quality representative with regulatory agencies, customers, partners, and auditors.

Develop and execute the global quality vision, strategy, and roadmap aligned with company objectives.

Establish a culture of quality, compliance, integrity, accountability, and continuous improvement throughout the organization.

Serve as a strategic advisor to executive leadership on quality, compliance, regulatory, and risk-related matters.

Lead and develop a high-performing global Quality organization capable of supporting growth and international expansion.

Drive quality excellence initiatives that support operational effectiveness, product reliability, and customer satisfaction.

Establish, maintain, and continuously improve an effective global Quality Management System.

Ensure QMS compliance with applicable regulatory agencies and

ICH guidelines, GMP/GxP regulations, and ISO standards, as applicable.

Oversee document control, change management, deviation management, CAPA, risk management, complaint handling, and quality metrics.

Ensure quality systems remain inspection-ready at all times.

Maintain global compliance with all applicable regulations governing biotechnology products and operations.

Lead preparation and management of regulatory inspections, customer audits, certification audits, and partner assessments.

Serve as executive sponsor during regulatory inspections and significant quality events.

Ensure timely investigation, root cause analysis, corrective actions, and preventive actions related to quality issues.

Monitor evolving regulatory requirements and implement necessary changes across the organization.

Provide quality oversight and support for manufacturing, laboratory operations, supply chain, distribution, and product lifecycle management.

Ensure product quality, safety, identity, purity, potency, and efficacy are maintained throughout development and commercialization.

Review quality trends, process performance, and compliance metrics to proactively mitigate risks.

Partner with cross-functional leaders to drive continuous improvement initiatives.

Direct Quality Assurance and Quality Control functions globally.

Ensure appropriate testing, release, stability, and validation programs are maintained.

Oversee qualification and validation of facilities, utilities, equipment, systems, and processes.

Ensure data integrity principles and controls are effectively implemented and maintained.

Establish and maintain robust supplier qualification and monitoring programs.

Oversee quality agreements and performance management of contract manufacturers, laboratories, vendors, and service providers.

Assess and mitigate quality and compliance risks across the global supply network.

Lead enterprise quality risk management activities.

Implement risk-based decision-making processes in accordance with industry best practices.

Escalate significant quality or compliance risks to executive leadership with recommended mitigation plans.

Support business continuity and product supply assurance activities.

Build, mentor, and develop global quality leaders and teams.

Foster employee engagement, accountability, and professional development within the Quality organization.

Establish succession planning and organizational capability-building strategies.

Promote cross-functional collaboration and strong business partnerships.

Educational Qualifications

• Required: Master’s degree in scientific discipline (such as Biology, Biotechnology, Biochemistry, Microbiology, Biomolecular, Pharmaceutical Sciences, or Engineering). 

Additional Qualifications

• 20 years of progressive experience in biotechnology, CDMO, biologics, cell & gene therapy, and/or pharmaceutical industry.
• Direct experience in CDMO and cGMP manufacturing operations.
• 10 years of direct people leadership experience, including performance management, growth and development, resource planning during production ramp-up, and developing a high-performing Quality organization.
• Demonstrated technical expertise in a multi-site operation with experience supporting clinical and commercial-stage biological products.
• Expertise in CAPA, deviations, investigations, data integrity, and audit management, with client-facing and auditor-facing experience.
• Strategic and analytical thinking, decision-making skills.
• Business acumen, executive-level communication and presentation skills.
• Ability to influence across functions and geographies.

Travel Requirements (10-20%)

Supervisor Responsibilities