Pfizer Director of Medical Device, Manufacturing and Pac in Kalamazoo, Michigan

ROLE SUMMARY•This position will be required to lead the Pfizer Kalamazoo medical device, manufacturing, inspection, and packaging function in a cGMP compliant environment. The leader will be responsible for Medical Device production, Liquid and Semi-Solid Manufacturing/Filling, Central Dispense, Powder Blending and Filling, Injectable Inspection, all finished product Packaging, as well as all associated capital and product transfer project support.•The leader will ensure that manufacturing methods / environment will meet contemporary industrial, Regulatory and Pfizer standards. He or she will work with the department leaders to ensure that departments are properly staffed to meet production requirements, to create and monitor budgets, to monitor and control production variances and ensure a safe working environment. The position will be responsible to interact with the sites quality assurance, quality control, validation, engineering, technology services, supply chain and regulatory departments in order ensure that regulatory standards, company policies and site processes are met.•This individual will cultivate and reinforce appropriate Pfizer values, norms, and behaviors and will provide oversight to individuals and teams on personal development, performance, and quality related issues. The position will provide oversight of the manufacturing teams and will write and deliver performance reviews and perform second level reviews as required.ROLE RESPONSIBILITIES•Direct the production of Medical Devices, Liquid and Semi-Solid Manufacturing/Filling (4 manufacturing modules and 7 filling lines, Central Dispense, Powder Blending and Filling (2 blending modules, and 4 fillingackaging lines), Injectable Inspection (10 lines), all finished product Packaging (18 packaging lines), as well as all associated capital and product transfer project support.•Ensure that the manufacturing departments are cGMP compliant.•Ensure that the departments are staffed to meet production requirements.•Creates, monitors and responsible for achieving department's budget. Monitors, reports and reacts accordingly to production variance reports.•Ensures a safe manufacturing environment is in place.•Ensures that all manufacturing methods and practices are consistent with industry and Pfizer standards.•Interacts with the sites quality assurance, quality control, validation, engineering, technology services, supply chain and regulatory departments to ensure the sites manufacturing needs, regulatory standards and company policies are met.•Ensures that colleague training programs are suitable and effective to support cGMP requirements.•Drive effective CAPA at key suppliers to improve quality compliance and efficiency of componentry.•Timely escalation of personnel, environmental, safety and manufacturing issues.•Provide strategic direction for operations master planning, preparation of business justifications with direct input to capital investments, and oversee product transfers.•Work across multiple functions and manage multiple competing priorities and requirements, including performing site and functional responsibilities. Note that these activities may not be time bound to core hours or presence at the siteBASIC QUALIFICATIONS•Bachelor's degree in Engineering, Science, or equivalent•15 years of directly related experience and at least 5 years in a drug product manufacturing environment.•10+ years of experience leading direct reports•Minimum of 5 years of managerial experience directing and developing staff level colleagues•Strong analytical, presentation and relationship management skillsbr