Sr. Manager, Quality Operations
Zoetis
5 months ago
On-site
Kalamazoo, MI
Operations
Position Responsibilities:
- Provide direct leadership for Quality Operations team, achieving objectives for colleague engagement, EHS, quality, supply, and cost.
- Build partnerships with site functions (supply chain, engineering, maintenance, technical services, procurement, 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; facilitate Daily Direction Setting, tiered communication/escalation, and lead Kaizen events.
- Develop and coach team members to build a high-performing, engaged, agile culture aligned with Zoetis Core Beliefs.
- Create and execute strategic plans for quality, compliance, operational goals, including cost improvements and process optimization.
- Prioritize/sponsor projects for operational improvements, growth, and expansion of quality capabilities.
- Develop, implement, and share best practices across the site and network.
- Represent Quality Operations in internal/external forums; act as a champion for quality and continuous improvement.
- Lead/mentor/develop Quality Operations staff (specialists, team leaders).
- Ensure effectiveness of processes including lot release, deviation investigations, change control, and regulatory/GMP inspection readiness.
- Develop/report key metrics to provide site leadership visibility into compliance, risk, and performance trends.
- Serve as site lead for regulatory inspections and customer audits.
- Drive Lean, Six Sigma, and continuous improvement initiatives.
- Collaborate cross-functionally (Operations, QC, Engineering, Supply Chain, etc.) to achieve site objectives.
- Sponsor strategic technology/process improvement projects.
- Ensure robust investigation, CAPA, and change management processes aligned to global/site standards.
- Represent Quality Operations in site/network forums to contribute to policy/strategy/best practice sharing.
- Manage the QO budget, resources, and talent pipeline.
- Perform other related duties as assigned by the Site Quality Leader.
Technical Skills & Qualifications:
- 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 (aseptic experience preferred).
- Minimum 5 years’ people leadership experience, including leading leaders/complex teams.
- Demonstrated expertise in cGMP, regulatory compliance, and quality systems.
- Significant experience with Lean and Six Sigma/process improvement (Green or Black Belt preferred).
- Strong track record leading through change 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 with quality/compliance systems (e.g., Veeva Vault, SAP, LIMS) and Microsoft Office Suite.
Physical Requirements:
- Work involves office and manufacturing environments; exposure to moving mechanical parts.
- 70% stationary, 30% standing/walking; required use of PPE.
- Must not be Cephalosporin/Penicillin sensitive.
- Provide direct leadership for Quality Operations team, achieving objectives for colleague engagement, EHS, quality, supply, and cost.
- Build partnerships with site functions (supply chain, engineering, maintenance, technical services, procurement, 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; facilitate Daily Direction Setting, tiered communication/escalation, and lead Kaizen events.
- Develop and coach team members to build a high-performing, engaged, agile culture aligned with Zoetis Core Beliefs.
- Create and execute strategic plans for quality, compliance, operational goals, including cost improvements and process optimization.
- Prioritize/sponsor projects for operational improvements, growth, and expansion of quality capabilities.
- Develop, implement, and share best practices across the site and network.
- Represent Quality Operations in internal/external forums; act as a champion for quality and continuous improvement.
- Lead/mentor/develop Quality Operations staff (specialists, team leaders).
- Ensure effectiveness of processes including lot release, deviation investigations, change control, and regulatory/GMP inspection readiness.
- Develop/report key metrics to provide site leadership visibility into compliance, risk, and performance trends.
- Serve as site lead for regulatory inspections and customer audits.
- Drive Lean, Six Sigma, and continuous improvement initiatives.
- Collaborate cross-functionally (Operations, QC, Engineering, Supply Chain, etc.) to achieve site objectives.
- Sponsor strategic technology/process improvement projects.
- Ensure robust investigation, CAPA, and change management processes aligned to global/site standards.
- Represent Quality Operations in site/network forums to contribute to policy/strategy/best practice sharing.
- Manage the QO budget, resources, and talent pipeline.
- Perform other related duties as assigned by the Site Quality Leader.
Technical Skills & Qualifications:
- 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 (aseptic experience preferred).
- Minimum 5 years’ people leadership experience, including leading leaders/complex teams.
- Demonstrated expertise in cGMP, regulatory compliance, and quality systems.
- Significant experience with Lean and Six Sigma/process improvement (Green or Black Belt preferred).
- Strong track record leading through change 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 with quality/compliance systems (e.g., Veeva Vault, SAP, LIMS) and Microsoft Office Suite.
Physical Requirements:
- Work involves office and manufacturing environments; exposure to moving mechanical parts.
- 70% stationary, 30% standing/walking; required use of PPE.
- Must not be Cephalosporin/Penicillin sensitive.