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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive leadership in Manufacturing Quality Operations, with a focus on biologics and biopharmaceuticals. Capable of driving quality strategy, compliance, and operational excellence across multi-site organizations while ensuring adherence to global regulatory standards.
Highest-signal resume keywords
Senior Manufacturing Quality Operations LeadershipCGMP Operating Models OptimizationTech Transfer and Validation GovernanceGlobal Quality and Compliance KnowledgeCross-Site Transformation and Change Management
ATS Keywords
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Hard Skills
Quality Strategy ExecutionDeviation/CAPA EffectivenessChange Control ManagementData Integrity OversightProduct Release GovernanceAnalytical Development and ValidationCommercial Supply ManagementQuality Culture DevelopmentRisk-Based GovernanceQuality Decision-Making
Soft Skills
Analytical SkillsWritten CommunicationVerbal CommunicationStakeholder ManagementTalent Development
Industry Keywords
BiopharmaceuticalsBioVaccinesFDA cGMP (21 CFR)EU GMP (EudraLex Vol. 4)ICH StandardsUSDA/APHIS RegulationsQuality OversightOperational ContinuityContinuous ImprovementGlobal Quality Leadership
About the role
Key responsibilities & impact- Provide platform-level leadership and independent governance for Manufacturing Quality (QA/QC) across internal BioPharmaceuticals and BioVaccines sites
- Own and execute the platform Quality strategy and translate business needs into objectives, targets, quality culture, and measurable improvements
- Lead quality oversight across the commercial manufacturing lifecycle from CMC registration through tech transfer, PPQ, launch, and ongoing supply
- Partner with VMRD/DS&T and GMS Process Owners on process and analytical development and validation
- Approve validation lifecycle strategy, set risk-based governance, and ensure rigorous documentation and quality decision-making
- Ensure compliance through CPV oversight, deviation investigations/CAPA, change control, data integrity, inspection readiness, and product release governance
- Co-lead platform Quality governance and facilitate the Platform Quality Council
- Drive harmonization, learning, innovation, digitalization, and predictive analytics across sites
- Build a scalable organization through talent development, retention, succession planning, and resourcing
- Represent BioPharmaceuticals and BioVaccines Manufacturing Quality with external bodies and contribute to Global Manufacturing and Global Quality leadership forums
- Lead teams across sites in the US, Belgium, Ireland, China, and Norway
- Deliver reliable supply, operational continuity, compliant launches, improved CMC outcomes, digitalized Quality processes, and faster batch disposition
Requirements
What you’ll need- Senior manufacturing Quality Operations leadership experience, with biologics/biopharma strongly preferred
- Proven record leading multi-site, international QA/QC organizations through complexity, change, and growth
- Experience building and optimizing cGMP operating models for BioPharmaceuticals and/or BioVaccines
- Experience with tech transfer, PPQ/validation governance, launch readiness, commercial supply, deviation/CAPA effectiveness, change control, data integrity, and product release
- Strong working knowledge of global Quality, Compliance, and Regulatory expectations, including GMP and GDP
- BS in Pharmacy, Biology, Biochemistry, Pharmaceutical Sciences, or related discipline
- Significant senior leadership experience in pharmaceutical/biological Quality Operations
- Deep familiarity with FDA cGMP (21 CFR), EU GMP (EudraLex Vol. 4), ICH, and USDA/APHIS standards and regulations
- Excellent analytical, written, and verbal communication skills
- Proven ability to lead cross-site transformation, continuous improvement, and change management
- Strong stakeholder management across regions, cultures, and levels
- Ability to scale QA/QC capacity and capability, improve quality cycle times, and enable growth through resource planning and productivity
- Fluent English, written and spoken, required
- Based in Dublin, Ireland or in the US
- Travel as required, typically up to 20%
- All applicants must possess or obtain authorization to work in the US for Zoetis
Benefits
Comp & perks- Short-term incentive compensation
- Long-term incentives
- Healthcare and insurance benefits beginning on day one
- 401K plan with a match and profit-sharing contribution from Zoetis
- 4 weeks of vacation
- Reasonable accommodations for individuals with disabilities