POSITION SUMMARY

The Regional Compliance Auditor will conduct on-site audits of Zoetis manufacturing sites, contractors and suppliers - with the goal of determining compliance gaps and necessary remediation plans. The auditor will promptly deliver/communicate audit findings using predetermined processes and methodology.

The RCA will (as needed) assist with mock regulatory inspections as well as supporting agency inspections. Additonally - the auditor will gather, track, trend, and disseminate regulatory compliance findings - from internal as well as external inspection sources.

The RCA will work closely with QSS and Surveillance colleagues to stay abreast of current compliance regulations and points of key inspection trends.

POSITION RESPONSIBILITIES

• Conducting quality audits of global and regional Zoetis Global Manufacturing and Supply Sites (GMS), Suppliers and Contractors
• Conduct Mock PAI and inspection readiness assessments at GMS Sites and contractors
• Support due diligence assessments
• Support regulatory agency inspections and conduct risk assessment of regulatory agency observations
• Follow up and tracking of CAPA completion
• Train sites and center colleagues on conducting audits (auditor qualification)
• Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis quality assurance programs.
• Zoetis Quality Culture ambassidor

ORGANIZATIONAL RELATIONSHIPS

• Manufacturing Operations
• Manufacturing GMT
• QSS, QPL
• VMRA VMRD
• GSS
• ESQA, SCQO
• Manufacturing IT

RESOURCES MANAGED

Supervision

Highly matrixed organization; Influence without authority necessary

EDUCATION AND EXPERIENCE

• Science or Engineering Bachelors / Masters Degree
• Significant Operations and/or Quality experience (5+ years) in Animal Health/Human Health manufacturing
• Previous Animal Health/Human Health audit experience
• Demonstrated ability to operate successfully in a matrix organization
• Six Sigma Black Belt / Green Belt or Lean Practioner Preferred
• Experience in working with FDA, EU, USDA, Chinese regulations.

TECHNICAL SKILLS REQUIREMENTS

• Demonstrated knowledge in Quality Operations
• Fluent with compliance regulators
• Excellent communication skills (written, oral, and listening)
• Demonstrated independent contributor and ability to manage independently
• Deep expertise in planning, organizing, and follow up methodology; punctual
• Ability to develop and adhere to self-directed standard work.
• Ability to analyze data and synthesize to enable tracking and trending of large issues
• Process Owner Management
• Continuous Improvement; Systems and Process mindset

PHYSICAL POSITION REQUIREMENTS

• Location: Shanghai or Suzhou
• Position requires flexible work hours, to accommodate varying sites, locations, and markets' time zones
• This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sites
• Travel: Estimated 50% global travel

ACRONYM DEFINITIONS

• QSS: Quality Systems and Standards
• QPL: Quality Platform Leader
• QA: Quality Assurance
• QC: Quality Control
• ESQA: External Supply Quality Assurance
• SC QO: Supply Chain Quality Operations
• GMS: Global Manufacturing and Supply
• VMRA: Vetrinary Medicine Regulatory Affairs

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2016, the company generated annual revenue of $4.9 billion with approximately 9,000 employees. For more information, visit www.zoetis.com