Product Development Quality Leader

Role Summary

Product Development Quality Leader responsible for guiding co-development teams in vaccine, biopharma and pharma collaborations, ensuring quality integration across product development, transfer to manufacturing, and post-validation stages.

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

• Bachelor's degree
• Experience across technical (chemistry, analytical, formulation, bioprocess development, etc) disciplines with a demonstrated track-record of constructive influence on product development teams.
• 10+ years pharmaceutical industry experience.

Preferred Qualifications

• Masters/Graduate Degree
• Quality Operations experience Strong leadership skills.
• Ability to work independently at a high level.
• Strong interpersonal skills and accountability in day-to-day interactions.