Role Summary
The Product Development Quality Leader will drive quality oversight for co-developed vaccines and biopharma programs in Zoetis' Veterinary Medicine Research and Development (VMRD) Product Quality group. They will participate in cross-functional co-development teams, guiding strategy from development through transfer to Global Manufacturing & Supply (GMS). The role ensures product quality by managing variation, risk assessments, and alignment of critical process parameters and specifications across development, validation, and transfer phases.
Responsibilities
- As part of the core co-development team, represent VMRD Product Quality through product development. 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, while driving efficiency.
- Interpret and stay updated on relevant regulation and guidelines from health authorities.
- Ensure that all processes, documentation, facilities, and products comply with requirements. Assure adherence to appropriate GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business lines.
- Ensure a proactive and adaptive approach to evolving project needs. Champion the implementation of 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 general 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 the qualification and verification phases of product lifecycle to ensure a seamless approach to process transfer and to knowledge management.
- Identify opportunities for automation and integrating technological solutions to simplify compliance tasks and improve quality.
- Demonstrate resilience in the face of challenges, maintaining composure and guiding the team through periods of change.
Qualifications
- Required: Bachelor's degree
- Required: Experience across technical (chemistry, analytical, formulation, bioprocess development, etc) disciplines with a demonstrated track-record of constructive influence on product development teams.
- Required: 10+ years pharmaceutical industry experience.
- Preferred: Masters/Graduate Degree
- Preferred: Quality Operations experience
- Preferred: Strong leadership skills
- Preferred: Ability to work independently at a high level
- Preferred: Strong interpersonal skills and accountability in day-to-day interactions
Education
- Bachelor's degree
- Master's/Graduate Degree (Preferred)
Additional Requirements
- On-site presence at least 50% of the time