Job Category
Analytical Chemistry: Works on separation, identification and quantification of chemical components of natural and synthetic materials. Designs and performs quantitative and/or qualitative analysis using classical and instrumental methods.

Job Description-
To provide overall management and leadership of the site quality control laboratory (s)
? Establish a vision for the laboratory community and design plan to achieve
? To drive change by delivering the strategy via means of culture, technology, organization, facilities and ways of working
? To provide leadership and guidance on all site laboratory activities.
? To manage laboratory resources such that they deliver both current and future business needs
? To provide the primary link between QA/Technical customers, suppliers, R&D and NPI process areas
? To provide pharmaceutical development/analytical expertise to QA/Technical laboratories
? To manage employee relations, H&S, GMP compliance
? To provide analytical data to support batch release, NPI projects and activities.
? Build an analytical community at site.

Must be in a Lab Manager / Lead Role.
Minimum 10 years of analytical experience in Pharmaceutical Quality Control or analytical development
1. Excellent people leadership – highly respected coach and mentor of lab staff
2. Excellent team and personal organizational/planning skills
3. In-depth knowledge of lab related QMS, Pharmacopeia, safety requirements and pertinent local regulations
4. Demonstrated willingness to collaborate with other site and off site leaders to share/exchange knowledge as appropriate.
5. Technical expertise in a broad range of analytical methodologies for testing API and\or drug products.
6. Ability to compile and analyze data effectively
7. Excellent verbal and written communication skills. Demonstrated ability to clearly communicate with direct reports, peers, and external customers. Demonstrated expertise in scientific writing
8. Extensive knowledge of Regulatory compliance requirements (e.g. ICH, FDA 21st Century GMPs) as they relate to analytical methods, laboratory controls and pharmaceutical quality
9. Working knowledge of the application of statistical techniques to quality processes.
10.Compliance experience in and participation in inspections and audits including GMP and regulatory inspections.
11. Proven ability to communicate and influence at most levels of management
12. Proven strong track record of project management skills.
13. Knowledge of Operational Excellence tools and ways of working
14. Understanding of key customer requirements both internal and external to site.
15. Experience in change and deviation management methodology
16. Understanding of business process of automation
17. Thorough understanding of data integrity as it relates to both manual and electronic records