Director-Global Quality Systems

Description MUST HAVE SAP EXPERIENCE

The Director of Quality Systems is responsible for providing and maintaining the Quality System for Animal Health to include; the maintenance of all Quality Manuals, key quality dates & information, and communication of quality policy and initiatives.

1. Provide communication about quality organization, quality targets and quality standards for AH.
2. Establish, implement and maintain NAH Quality Manual
3. Define and implement IT systems for surveillance of compliance processes
4. Supervise deviation and complaint handling process for international products
5. Support and coordinate global training
6. Responsible for the maintenance of Global SOPs
7. Track progress on various quality initiatives and interfaces of group quality on key global pro-jects as assigned. Bachelor's degree in Science, Engineering, Math or related field.

 15+ years experience in regulated industry; 5+ years in leadership role.
 Technical knowledge of various drug manufacturing process
 Experience in Quality Assurance & Quality Systems management.
 in-depth knowledge of chemical/pharmaceutical processes
 In-depth knowledge of regulatory requirements for GMP (Swissmedic, EMEA, FDA) and other international institutions (e.g., VICH, ISPE, PDA
 In-depth knowledge of Computerized System Validation,Standard industry systems e.g., SAP, Trackwise etc. and computer system operation principles