Sr. Manager, Quality Operations

Overview

The Sr. Manager, Quality Operations (QO) is a key member of the site Quality Leadership Team, responsible for strategic and operational leadership of Quality Operations functions, including Floor Support, Lot Release, Regulatory/GMP Inspections, Deviation Investigations, Change Control, and related compliance activities. This role ensures compliance to cGMP and regulatory requirements, drives continuous improvement, and fosters a culture of quality and operational excellence.

The Sr. Manager, QO, leads and develops a high-performing team, collaborates cross-functionally, and represents Quality Operations to internal and external stakeholders, including regulatory agencies and customers.

• Provide direct leadership for Quality Operations team, achieving objectives for colleague engagement, EHS, quality, supply, and cost.
• Build strong partnerships with site functions, including supply chain, engineering, maintenance, technical services, procurement, and logistics, to ensure end-to-end compliance and operational excellence.
• Oversee and optimize Quality Operations processes to support lead time reduction, risk management, and on-time delivery of quality/compliance requirements.
• Role-model Lean leader behaviors and vigorously support implementation of tactical Lean improvements, including facilitating Daily Direction Setting, tiered communication and escalation, and leading Kaizen events.
• Develop and coach team members to build a high-performing, engaged, and agile culture, aligned with Zoetis Core Beliefs.
• Create and execute strategic plans to achieve quality, compliance, and operational goals, including cost improvements and process optimization.
• Prioritize and sponsor projects that support operational improvements, growth, and expansion of quality capabilities.
• Drive the development, implementation, and sharing of best practices across the site and network.
• Represent Quality Operations in site, network, and external forums, acting as a champion for quality and continuous improvement.
• Lead, mentor, and develop Quality Operations staff, including specialists and team leaders, fostering a high-performance and continuous improvement culture.
• Oversee and ensure the effectiveness of Quality Operations processes, including lot release, deviation investigations, change control, and regulatory/GMP inspection readiness.
• Develop, report, and act upon key metrics to provide site leadership with clear visibility to compliance status, risk, and performance trends.
• Serve as site lead for regulatory inspections and customer audits, including direct engagement with external agencies and clients.
• Drive Lean, Six Sigma, and other continuous improvement initiatives to enhance quality, efficiency, and compliance.
• Collaborate with site leadership and cross-functional teams (Operations, QC, Engineering, Supply Chain, etc.) to achieve site objectives for colleague engagement, EHS, quality, supply, and cost.
• Sponsor and facilitate strategic projects, including technology and process improvements, to support growth and compliance.
• Ensure robust investigation, CAPA, and change management processes in alignment with global and site standards.
• Represent Quality Operations in site and network forums, contributing to policy, strategy, and best practice sharing.
• Manage the QO budget, resources, and talent pipeline to ensure sustainability and capability growth.
• Perform other related duties as assigned by the Site Quality Leader.

• Bachelor's degree in a science-related field (e.g., Microbiology, Chemistry, Engineering); advanced degree preferred.
• 10+ years' experience in Quality Operations, Quality Assurance, or related pharmaceutical/biotech manufacturing roles.
• Minimum 5 years' experience in people leadership, including leading leaders and/or complex teams.
• Demonstrated expertise in cGMP, regulatory compliance, and quality systems.
• Significant experience with Lean, Six Sigma, and/or process improvement methodologies (Green or Black Belt preferred).
• Strong track record of leading through change, driving performance, and building high-performing teams.
• Excellent communication, stakeholder management, and presentation skills.
• Proven ability to interact effectively with regulatory agencies and external partners.
• Strong analytical, decision-making, and project management skills.
• Proficiency in quality/compliance systems (e.g., Veeva Vault, SAP, LIMS) and Microsoft Office Suite.

• Work involves office and manufacturing environments, with exposure to moving mechanical parts.
• 70% stationary, 30% standing/walking; required use of PPE.
• Must not be Cephalosporin/Penicillin sensitive.

Full time Regular Colleague

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