Sr. Manager, Quality Operations

Zoetis•Kalamazoo, MI

About The Position

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.

Requirements

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.

Responsibilities

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.