Site Quality Lead at Zoetis

Kalamazoo, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Animal HealthIndustries

Requirements

Leadership experience in quality management, including stewardship of quality culture and quality management systems
Expertise in regulatory compliance, cGMPs, FDA, and European agency requirements
Ability to maintain site inspection readiness and act as point of contact for inspections
Proficiency in risk assessment processes, supplier quality programs, audits, and qualification
Skills in developing and executing quality plans, roadmaps, metrics, and validation master plans
Experience in data analysis, process improvement, and investigating customer complaints
Capability to oversee QC testing standards, methods, and procedures for raw materials and finished products
Strong collaboration skills with site leadership, global quality organizations, and other functions
Budgeting and resource planning experience
Leadership and coaching abilities for staff development and training plans

Responsibilities

Ensure product quality and site's regulatory compliance, including adherence to cGMPs and inspection readiness
Champion and reinforce quality culture across the site and within the quality function
Participate as a member of the Site Leadership Team, contributing to strategic direction and day-to-day quality operations
Co-chair the Site Quality Council to drive continuous improvement, compliance objectives, and quality culture initiatives
Lead the Site Risk Assessment Process on a predetermined cadence
Use data and metrics to drive continuous improvement in quality management systems and product quality
Create and execute the Site Quality Roadmap
Oversee implementation and sustainability of quality standards and management systems
Ensure products are manufactured and released in compliance with regulatory standards and registration files
Promote compliance, remediate audit findings, and maintain quality standards site-wide
Oversee QC testing to meet regulatory compliance and GMPs
Manage supplier quality programs, including audits and qualification
Develop and implement the Quality Plan / Quality Roadmap
Develop metrics for product and process improvement
Ensure the Validation Master Plan is compliant and up to date
Collect and analyze process data for new or modified products/processes
Investigate quality-related customer complaints
Collaborate with other sites and organizational leadership on quality management activities
Champion leadership development, coaching of staff, and creation of a learning organization
Ensure training and development plans for all quality associates
Develop site quality budget and resource planning
Support development of quality goals and targets as part of the organization's strategic plan

Skills

Key technologies and capabilities for this role

cGMPRegulatory ComplianceFDAQuality Management SystemsInspection ReadinessRisk AssessmentContinuous ImprovementQuality CultureLeadershipMetrics Analysis

Questions & Answers

Common questions about this position

What is the reporting structure for the Site Quality Lead role?

The position reports to the Platform Quality Leader and is a member of the Site Leadership Team.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What are the key responsibilities of the Site Quality Lead?

The role is accountable for product quality, regulatory compliance, cGMP adherence, inspection readiness, quality culture championship, Site Risk Assessment Process ownership, and creating the Site Quality Roadmap.

What is the company culture like for this role?

The role champions and stewards the quality culture across the site, co-chairs the Site Quality Council to drive continuous improvement and compliance objectives, and emphasizes proactive steps for high levels of quality and compliance.

What experience makes a strong candidate for this position?

Strong candidates will have leadership experience in quality management, regulatory compliance including FDA and European agencies, cGMPs, risk assessment processes, and driving continuous improvement through metrics and quality roadmaps.