Site Quality Lead

POSITION SUMMARY

The Site Quality Lead role is responsible for the leadership and oversight of all Quality functions at the site, including Quality Assurance, Quality Control, Quality Operations, and Compliance. This role ensures that product quality and the site’s regulatory compliance are maintained at the highest standards, fostering a state of inspectional readiness.

• Establishing / Reinforcing the Quality Culture on the Site.
• Maintain Site Inspection Readiness.
• Promote Compliance Audit findings/remediation.
• Ensure that products are manufactured in compliance with current processes.
• Ensure Product Release is done within current quality standards.
• Ensuring QC Testing meets within current quality standards.
• Proactive Ownership of the Site Risk Assessment process.
• Oversee the development and implementation of the Quality Plan / Quality Road Map
• Share Leadership of Site Quality Councils and Metrics
• Develop metrics to deliver product and process improvement.
• Maintain the Supplier Quality program and vendor certification.
• Create and be accountable for the Site QA/QC Budget.
• Champion Leadership Development for the Site Quality Staff.
• Overall Site Product Portfolio Quality Stewardship owner and accountability.
• Facilitate agency inspection and notified body audits.

• Leadership Development / Coaching of Staff;
  Creation of Learning Organization
• Stewardship of the Quality Culture within the QA Function as well as the Site.
• Ensure Training and Development plans are in place for all QA associates.
• Development of Site QA operations budget and resource planning for roll up to the Site Quality Budget.
• Strong Communication skills written and verbal.
• Support the development of Quality goals and targets as part of the organization’s strategic plan.

• Quality Platform Lead
• Global QSS
• Manufacturing Site Leadership
• Corporate Quality Auditing
• Site Enabling Functions (ie: Engineering; GMT; Finance etc)
• Operational Excellence
• VMRA and VMRD

Financial Accountability

• Manage department budget in addition to personnel costs. Responsible for ensuring plant stays in compliance with all applicable entities so as to ensure continuous supply of products.

• Direct /Indirect: 3 / 2 staff reports
• Quality Unit also utilizes approximately 1-2 temporary contract workers (contingent employees)

• Bachelor’s degree in Science or Engineering required; advance degree preferred.
• Proven leadership experience in a Quality function within Animal Health or Human Health Medical Device industries
• 7-10 years of progressive Quality experience in biological device and/or automation manufacturing environments.
• Extensive background in GMP and ISO 9001 regulated operations.
• Proficiency in lean manufacturing methodologies
• Exceptional communication, problem-solving, and team development skills

• Leads in Change Management environment, Acts as a Change Agent
• Problem solver root cause analysis methodology
• Process oriented mindset; data and continuous improvement orientation
• Able to work well in complex environment.
• Experience in SAP/PLM systems
• Facilitate inspections

• Position located in Durham, NC
• Minimal off-site travel
• Occasional non-core hour work anticipated

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability.

Please contact Zoetis Colleague Services at zoeti to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain…