Product Development Quality Leader

Role Summary

Product Development Quality Leader responsible for guiding co-development teams in vaccine, biopharma and pharma collaborations to ensure product quality and compliance throughout the lifecycle, including transfer to manufacturing and supply.

Responsibilities

• Represent VMRD Product Quality within core co-development teams to prioritize processes, roadmaps, and drive innovation in product development.
• Provide strategic input and collaborate to implement innovative solutions to improve processes and reduce compliance risk while driving 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 GMP practices; anticipate and address emerging challenges across business lines.
• Maintain a proactive approach to evolving project needs; champion efficient and compliant processes; foster a culture of quality and continuous improvement.
• Apply a quality-embedded mindset and knowledge of industry and customer requirements to define appropriate actions.
• Lead investigations, corrective/preventive actions, and change control activities within quality management systems during the design phase.
• Partner with Quality Operations in GMS during qualification and verification phases to ensure seamless transfer and knowledge management.
• Identify opportunities for automation and technological solutions to simplify compliance tasks and improve quality.
• Demonstrate resilience and guide the team through periods of change.

Qualifications

• Basic Qualifications: Bachelor's degree; experience across technical disciplines with a track record of influence on product development teams; 10+ years pharmaceutical industry experience.
• Preferred Qualifications: Master's/Graduate Degree; Quality Operations experience; strong leadership; ability to work independently at a high level; strong interpersonal skills and accountability in day-to-day interactions.

Skills

• Regulatory interpretation and compliance
• Quality management systems and change control
• Cross-functional collaboration and program leadership
• Process design and validation concepts
• Risk assessment and decision making
• Quality documentation review and approval

Education

• Bachelor's degree required; Master's/Graduate Degree preferred.

Additional Requirements

• On-site presence expected ‚â•50% of the time.