:
1. Lead quality operations and provide quality oversight for manufacturing operations, laboratory activities, and quality systems
2. Work with cross- functional teams to ensure compliance and drive quality excellence
3. Foster a culture of quality excellence across the organization
4. Develop and lead high- performing teams dedicated to delivering exceptional results for our customers
5. Host and manage regulatory inspections and customer audits
6. Implement and maintain robust quality systems, including document control, change control, deviations, CAPA, and validation
7. Drive continuous improvement initiatives and apply risk management tools
REQUIREMENTS:
Qualifications:
8. Advanced Degree plus proven experience, or Bachelor's Degree plus proven years of experience in GMP/regulated environment, including time spent in a leadership role
9. Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy or related
10. Additional certifications (ASQ, Six Sigma, etc.) are desirable
Knowledge and Skills:
11. Comprehensive knowledge of FDA and international GMP regulations
12. Strong understanding of quality systems and their implementation
13. Demonstrated success in leading quality operations and developing quality assurance staff
14. Strong project management and cross- functional leadership abilities
15. Excellent analytical and problem-solving skills with data- driven decision making
16. Strong written and verbal communication skills, including technical writing
17. Proficiency with quality systems software
18. Knowledge of risk management tools and continuous improvement methodologies
Additional Requirements:
19. Ability to travel occasionally (10-20%)
What We Offer:
20. Competitive salary and benefits package
21. Career development opportunities within a global organisation
22. Collaborative and innovative work environment
23. Opportunity to make a meaningful impact on global health and safety