AVP, External Quality
$282,200–$444,200 year
On-siteDublin, Leinster, Ireland or Zürich, Zurich, Switzerland
Job Summary
Lead the strategy, organizational design, and budget oversight for a global External Manufacturing Quality team of approximately 100 professionals. Establish and maintain a risk-based quality oversight framework for roughly 30 external manufacturing sites supporting cell banking, drug substance, and drug product operations. Direct quality oversight of external partners to ensure products are manufactured, tested, packaged, and released in accordance with global regulatory expectations. Drive timely product release, lead major quality investigations including root cause assessment and recall coordination, and provide strategic quality support for technology transfers and pre-approval inspections. Chair the External Manufacturing Quality Council and communicate key risks to senior leadership. This role reports to the Vice President of Quality, Global Biologics, and involves approximately 30% travel.
Required Qualifications
- Bachelor's degree in a scientific discipline
- Minimum of 10 years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements
- Demonstrated experience leading quality oversight of third-party manufacturers in a regulated environment, ideally within FDA/cGMP and global regulatory settings
- Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions
- Strong compliance background with experience supporting regulatory inspections and health authority interactions
- Significant experience across quality operations, including quality laboratories, batch release, quality assurance, and quality systems
- Demonstrated success leading and developing large, global, matrixed teams
- Experience with biologics and vaccines manufacturing across multiple nodes, including drug substance, drug product, packaging, and laboratories
- Experience supporting technology transfers, product launches, pre-approval inspections, and facility start-up activities
- Ability to travel approximately 30% of the time, including occasional short-notice travel
- Auditing
- cGMP Compliance
- Commercial Agreements
- Cross-Cultural Awareness
- Customer-Focused
- Detail-Oriented
- Ethical Compliance
- GMP Compliance
- Interpersonal Relationships
- Operational Excellence
- Organizational Design
- Patient Safety
- People Leadership
- Pharmaceutical Manufacturing
- Quality Assurance (QA)
- Quality Improvement Programs
- Quality Investigations
- Quality Management System Improvement
- Regulatory Compliance
- Results-Oriented
- Risk Assessments
- Strategic Initiative
- Supplier Quality Management
- Supplier Relationship Management
Desired Qualifications
- Advanced degree in a relevant scientific or technical field
- Experience leading global external manufacturing quality networks across both biologics and vaccines
- Prior leadership of a large multinational quality organization with direct accountability for partner performance, compliance, and supply support
- Strong knowledge of quality governance models, supplier oversight, and risk-based quality management systems
- Experience partnering with senior leadership at external manufacturing sites to influence performance, strengthen quality systems, and accelerate remediation
- Broader exposure to operations, engineering, supply chain, and commercial functions
- Deep familiarity with global regulatory agencies and inspection readiness, including FDA, EMA, TGA, and ANVISA
- Experience leading quality transformation, standardization, or continuous improvement initiatives across a global external manufacturing network
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