Product Development Quality Leader 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

Veterinary Medicine, Pharmaceuticals, BiopharmaIndustries

Requirements

Highly skilled, detail-oriented, and forward-thinking
Knowledge from product and process development to establish manufacturing process control
Understanding of variation, impact of variation, and control of variation in process/product development
Ability to apply appropriate level of quality and compliance across process design stage of process validation
Involvement in risk assessments, determination of Critical Process Parameters, Critical Quality Attributes (specifications), and control strategies
Experience collaborating with VMRD and GMS
Responsible for supporting multiple projects and interfacing with partner groups (global development teams, regulatory, GMS quality, formulation, chemistry, analytical, bioprocess development, PK/PD, clinical, CROs, etc.)
Adhere to being present on-site ≥50% of the time

Responsibilities

As part of the core co-development team, represent VMRD Product Quality through product development
Provide input on co-development strategy (clinical/PK supplies, design of experiments, analytical method development and transfer, registration batch manufacture, submission planning, etc.) throughout the project lifecycle, including transfer to Zoetis Global Manufacturing & Supply (GMS)
Guide co-development teams with a quality mindset to assure long-term product sustainability as a process design deliverable
Ensure variation, impact of variation, and control of variation is understood and well documented during process/product development
Participate in key decision making and supportive processes such as risk assessments, determination of Critical Process Parameters, Critical Quality Attributes, and control strategies
Partner with GMS across qualification and verification phases of validation for seamless transition to commercial manufacturing
Foster a culture of excellence and harmonize practices across diverse projects
Review and approve GMP documentation (batch records, protocols, reports, stability, etc.) for each project
Maintain and continuously improve VMRD Quality Management System policies in accordance with regulatory requirements, Zoetis standards, and industry best practices
Provide strategic input and participate in highly matrixed cross-functional teams with operational leaders to prioritize processes and roadmaps and drive innovation
Collaborate to develop and implement innovative solutions to improve business processes, reduce compliance risk, and drive efficiency
Interpret and stay updated on relevant regulations and guidelines from health authorities
Ensure all processes, documentation, facilities, and products comply with requirements and adhere to appropriate GMP practices with a forward-looking perspective
Ensure a proactive and adaptive approach to evolving project needs and champion efficient and compliant processes
Foster a culture of quality and continuous improvement
Use a quality-embedded mindset and practical knowledge of industry, customer requirements, and business environment to define appropriate actions
Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, and change control activities in the design phase
Partner with Quality Operations in GMS during qualification and verification phases to ensure a seamless approach