Director, IMEx Quality, North America, New Jersey USA
A Senior Opportunity at a Global FMCG Powerhouse:
Providing leadership to the quality assurance and quality control functions to assure that all products and procedures are in full compliance with all regulatory requirements and internal corporate standards.
Recommending and establishing policy to enable the company to continuously meet or exceed the expectations that the company delivers product meeting the highest quality standards and consistently meet our customer needs
- Overall leadership in the areas of quality management systems, regulatory compliance, quality control laboratory functions, documentation control, quality audit functions, both internally and with contract manufacturers and packagers.
- Responsible for developing/ deploying the Quality strategic plan and assuring the integration/ alignment into commercial quality strategy
- Interfaces with the Commercial President in areas of quality decisions, such as escalations, field actions and or other significant quality issues
- Act as the primary interface with international, federal, state and local regulatory officials in regards to the manufacture and release of any drug product and medical devices in North America.
- Ensures QMS supporting commercial businesses are in constant state of readiness for planned and ad hoc regulatory audits or inspections.
You will have:
- Demonstrated leadership in developing and implementing business / quality processes and strategies, leading managerial and professional technical personnel, and coordinating the execution of multiple complex projects in a fast paced environment.
- Strong working knowledge of applicable parts of Title 21 of the CFR and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical or medical device industry.
- Experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem solving teams, etc.
- Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers.
- Bachelor's degree in a scientific or technical field such as Chemistry, Chemical Engineering, Industrial Engineering, Mechanical Engineering, or Manufacturing Engineering.
- Highly ambitious, to be part of an elite global team with huge meritocratic advancement potential.
If you feel you are qualified and ready for this outstanding challenge, please contact our exclusive headhunter Duncan for a full, confidential discussion today on +44 1202 888 986 ext 262