Role Summary
The Manager Quality Operations / Team Leader will be responsible for planning, organizing, supporting and supervising Quality Operations personnel working with Floor Support; Lot Release; Regulatory/GMP Inspections; Deviation investigations; Change Control, and other related compliance activities. The manager will develop and report metrics to ensure management in Operations and QO is aware of the status of compliance, and will be accountable for the efficiency, accuracy, and service levels of unit personnel, supporting daily operations and budget. The role may lead improvement projects and serve as a primary contact for escorting and facilitating visits by outside regulatory agencies and other GMP/ISO compliance inspectors.
Responsibilities
- Reporting to the Site Quality Lead, oversee a staff of salary and overtime-eligible colleagues in Quality Operations areas including Quality Operations Specialists, Lot Release Specialists, and other related compliance activities.
- Develop and report metrics to ensure management in Operations & QO are aware of the status of compliance.
- Ensure efficiency, accuracy and service levels of unit personnel; support daily operations and budget.
- Initiate and lead continuous improvement projects.
- Learn and manage other responsibilities as assigned.
Skills
- Leadership, operational management, data and financial analysis, supply chain, decision-making, critical-thinking and technical skills related to quality operations, negotiating, and conflict resolution.
- Strong working knowledge of cGMP and current regulatory/compendial requirements.
- Knowledge of Quality Assurance principles.
- Experience with Lean Six Sigma principles and tools.
- Strong verbal and written communication, with excellent presentation skills.
- Demonstrated innovation, performance focus, change management, continuous improvement, and development/implementation of best practices.
- Track record of understanding and meeting customer and market needs.
- Proven performance management, coaching, and mentoring of team members.
- Commitment to Zoetis Core Beliefs.
- Excellent computer skills (Microsoft Office, Outlook) and ability to learn Zoetis systems.
- Proficiency in ETS, Veeva Vault, SAP, Z-LIMS, and inspection systems/software preferred.
- Position may cross-train in other QA roles as required.
Education
- Bachelor's degree in a Science-related field with 7-10 years of quality operations experience.
- Two+ years supervisory experience required.
- Strong working knowledge of Good Manufacturing Practices and current regulatory/compendial requirements.
- Strong interpersonal, oral, and written communication skills.
- Demonstrated successful interaction with all levels of personnel; knowledge of Quality Assurance principles.
- Aligned with Zoetis Core Beliefs.
- Note: Candidate must not be Cephalosporin or Penicillin sensitive.
Physical Requirements
- The work environment includes both office and manufacturing settings; may require use of Personal Protective Equipment including hard hats, safety shoes, eye protection, gloves, and protective clothing.
- Working conditions: approximately 70% stationary and 30% standing/walking; exposure to moving mechanical parts.