Corporate Quality Manager - Laboratories

OVERVIEW

The Corporate Quality Manager - Laboratories is responsible for the standardization of laboratory operations across the enterprise including instrument selection, methods of analysis, proficiency testing support and guidance, and general laboratory design and personal practices. Additionally, the position leads the coordination of third‑party testing to support supplier qualification and monitoring, unique finished product testing, and other unique testing which is not a part of the capabilities of the operating facilities.

The incumbent is also responsible for maintaining awareness of and understanding of pharmaceutical / national formulary (NF) / USP monographs and methods and supporting those sites which manufacture products to these standards. Responsibilities also include the use of laboratory scale testing to evaluate process aids, chemicals, and existing and alternate process technologies and support technology transfer for in‑line measurement.

• Global

• Bachelor's Degree in a scientific discipline from an accredited university plus at least 5 years of commercial laboratory or industrial operations experience
• Knowledge of Quality Assurance/Control practices and procedures
• Experience in communicating with 3rd party labs and suppliers
• Previous leadership / supervisory experience in a manufacturing environment
• HACCP and/or related food safety training
• Knowledge of the operation and calibration of laboratory equipment

• Degree major in Chemistry, Biology, or Food Science is preferred
• Knowledge and understanding of sugar refining technologies and required process aids
• Experience in ISO/IEC 17025 implementation and maintenance of accreditation
• Continuous Improvement (CI) knowledge and experience (i.e. Lean Six Sigma, Black/Green/Yellow Belt, 5S, etc.)

• 20-40% primarily in North America including short notice travel requests.

• Establish and maintain standards for ASR site quality laboratories in terms of procedures, equipment employed and overall appearance and operation
• Establish, maintain, and monitor unique testing for specific customers (i.e. quarterly & annual testing)
• Support the laboratory proficiency testing program which ensures methods and analysts are evaluated on an annual basis
• Establish and maintain an internal laboratory auditing program.
• Lead the Laboratory Community of Practice which includes Laboratory Supervisors and other Quality team members from the operating sites.
• Work collaboratively with the Supplier Quality team in the coordination of third‑party testing for supplier qualification / monitoring and with the operating sites for specific finished product monitoring.
• Champion standards for any site laboratory renovation projects in cooperation with Corporate & site Engineering along with site Quality and Laboratory leaders.
• Process aid and process technology modeling and testing
• Quality testing method development, validation, and standardization
• Support of new product development initiatives and test methods for these products
• Routine interaction with Research & Technology (R&T) & Boca Raton Innovation Center (BRIC)
• Maintain and act as ASR technical liaison in matters concerning the pharmaceutical (NF/EP/USP/etc.) business
• Provide technical training to laboratory, manufacturing and general staff as required
• Complete laboratory testing for corporate samples as required
• Performs other duties as assigned

• Ability to analyze complex information and perform root cause analysis
• Ability to recognize areas for Continuous Improvement strategies; recommend and implement CI strategies as assigned
• Ability to utilize ERP information and analyze results
• Ability to maintain confidentiality of proprietary business information at all times
• Ability to effectively manage time, including the ability to prioritize, work within assigned deadlines, and work independently or collaboratively to accomplish organizational objectives
• Ability to manage multiple tasks and projects while maintaining quality & accuracy standards
• Ability to utilize Microsoft Office Suite,…