Executive Director, Global External Quality

Job Summary

The Global Head of External Quality is responsible for leading the quality strategy, oversight, and compliance of the company's global external manufacturing network, including CMOs, CDMOs, contract laboratories, and other GMP-relevant third parties. This role provides end to end quality oversight for externally manufactured small molecule, large molecule/biologic, and finished drug products supporting both commercial and clinical supply across multiple markets. The incumbent ensures outsourced operations are compliant with global regulatory requirements, internal quality standards, and patient safety expectations.

Responsibilities

• Lead the global external quality function responsible for oversight of CMOs, CDMOs, contract testing laboratories, packagers, and other critical suppliers.
• Establish and maintain a risk based external quality oversight model across commercial and clinical products.
• Ensure compliance of external manufacturing operations with applicable global GMP, ICH, and regional regulatory requirements.
• Provide quality oversight for small molecules, biologics/large molecules, APIs, drug substance, and finished products throughout the product lifecycle.
• Oversee key external quality systems, including deviations, investigations, CAPA, change control, OOS/OOT, data integrity, validation, documentation, and training.
• Ensure robust supplier qualification, onboarding, performance monitoring, and periodic review of external partners.
• Lead quality input and decision making for technology transfers, product launches, lifecycle changes, site changes, and new supplier introductions.
• Ensure effective quality governance through quality agreements, escalation processes, performance metrics, and business review mechanisms.
• Lead inspection readiness and support regulatory inspections, audits, and remediation activities involving external sites.
• Escalate significant quality or compliance risks to senior leadership with clear risk assessments and recommended actions.
• Partner with internal stakeholders to support product disposition, supply continuity, issue resolution, and market action management, as needed.
• Build and lead a high performing global external quality team and foster a proactive, risk based quality culture.

Additional Responsibilities

• Accountable for Quality and Compliance decisions across CMOs, CDMOs, CTOs, including product disposition decisions as per cGMPs.
• Set quality and compliance goals and objectives; establish metrics to continuously monitor site quality performance; ensure goals are effectively met.
• Lead the External Quality Site Quality Review Team (SQRT) processes to ensure external manufacturer regulatory compliance and identify opportunities for continuous improvement.
• Provide technical direction and leadership for quality review of product documentation, including deviations, investigations, CAPAs, and health authority observations; represent Quality in site governance meetings.
• Shape and influence quality perspective and actions based on regulatory inspections and third party audits.
• Oversee compliance audits and regulatory inspections by health authorities (e.g., FDA, EMA, HPRA, PMDA) ensuring external sites inspection readiness.
• Provide expert interpretation and application of regulatory guidelines to ensure manufacturing operations, facilities, and documentation adhere to regulatory requirements.
• Sponsor quality and compliance harmonization, integration, and continuous improvement initiatives across GEO.
• Partner and align with Quality Site Heads to drive global quality strategic initiatives in alignment with technical operations objectives.
• Interface with senior management to set policy on product quality and assure adherence to company and governmental standards.

Leadership Responsibilities

• Embodies a compliance, quality, and continuous improvement mindset.
• Maintains high standards of performance, collaborates with stakeholders, and follows through on commitments.
• Conveys a sense of urgency and drives issues to closure with timely decisions.
• Works closely and collaboratively with global external operations, supply chain distribution, global quality functions, regulatory, technical development, clinical operations, manufacturing science and technology, and finance to achieve business goals.
• Builds, develops, and leads an engaged workforce, driving a high performance culture that is innovative, agile, open to change, and constantly learning.
• Manages selection, hiring, and training of personnel on company and department policies, systems, and processes.
• Leads quality AOP, forecast, and long range financial budgeting, ensuring adherence to budget.
• Sponsors project teams and champions deployment of new technologies and systems to improve quality, optimize productivity, reduce cycle times, and deliver pipeline.

Education

• BS/MS/B.Sc./M.Sc./PhD in the life sciences or engineering.

Experience

• At least 15 years of relevant leadership experience in Quality, including site quality leadership and at least 10 years supervising, managing, and directing teams.
• Demonstrated knowledge of cGMPs, global health authority regulations and guidelines, quality systems, and technical expertise in drug substance/product/finished goods manufacturing processes and combination products.
• Strong commercial bio/pharma manufacturing experience and excellent people leadership expertise; experience in biologics or cell/gene therapy manufacturing required, cell/gene therapy experience preferred.
• Exposure across multiple quality and technical operations functions; experience leading quality in multi product manufacturing plants with strong knowledge of health authority inspections and interactions.
• Excellent interpersonal and collaboration skills with strong oral and written communication.
• Demonstrated ability to implement processes that deliver results.
• Financial management experience, awareness, and strong acumen.

Contacts

This position interacts with all other departments throughout the organization and requires constant contact with senior management across the organization.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.