The Global External Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”
Job Summary
The Global External Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”
Manage all aspects related to product quality or compliance for a complex portfolio of external contract manufacturers and suppliers that supply Product(s) globally.
Develop ideas and lead complex crossfunctional project teams including internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D), anticipate potential challenges the team may encounter, and be responsible for the team’s deliverables and milestones.
Matching Summary
The Global External Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”
Skills & Requirements
Must-have
GMP and GDP adherence
Quality Improvement Plans
Product Quality decisions
Quality agreements
Annual Product Review reports
Batch disposition endorsement
Continuous improvement initiatives
Nice-to-have
Innovative Quality Systems
Risk-based decision making
Innovative solutions
Interest in Innovation
Key Requirements
Minimally Bachelor of Science Degree
Minimally 10 years’ experience in Pharmaceutical Quality Assurance
15 years’ experience in pharmaceutical industry
Experience with external suppliers/contractors
Advanced computer skills
Proficient in English
Strong verbal, written communication, and presentation skills
Demonstrated personal leadership
Demonstrated experience managing complex quality and compliance activities