Pfizer GMP Training Manager / TL in Kalamazoo, Michigan

ROLE SUMMARYAccountable for the development, delivery, assessment, continuous improvement and maintenance of the Kalamazoo Training Quality System and supporting programs, documentation, and courses and site orientation programManages the GMP Training and Records Retention Library personnel to ensure compliance to global, site, regulatory, and customer requirements, policies, processes and standardsServes as the Site Training Lead with matrix responsibility for other Business Area Training Leaders to ensure alignment with site training initiatives and compliance requirementsAccountable for change management of training within the Quality Tracking System (QTS). Supports process ownership of curricula, On-The-Job Training (OJT), and Standard Operating Procedures (SOPs) and corresponding periodic review processesInteracts and works effectively with all business areas, including the Kalamazoo Leadership Team, Global Quality, Global Training and SMEs within Quality to support GMP and site training initiativesROLE RESPONSIBILITIESProvide leadership and coaching to direct report colleagues and contractors, including setting annual objectives and developing and maintain annual training and records retention budgetsServe as the site point of contact for Global Training initiatives and coordination of cross-site orientationEstablish, measure, trend and report site training and SOP metrics monthly to Site Quality Review Team (SQRT)Approve site level training materials, e.g. SOPs, OJTs, CBTs, Curricula, etc.Manage development, assignment and completion reporting for annual GMP concept training as well as assignment and reporting for enterprise training at and above site (e.g. Blue Book, Your Reporting Responsibility, Collaborate Securely)Ensure communication of changes in site training, SOP, record retention systems or processes and system availability (e.g. PLS, CICR)Design, implement and lead Training Forums and Networks across site (e.g. Training Network Team)Manage on time completion and reporting of training internal audits (QASAs)Benchmark with Pfizer sites for proactive system improvements and provide benchmarking to support network best practicesEstablish and maintain relationships with record retention suppliersRepresent Kalamazoo within the Pfizer learning network and CICR community of practiceDeliver / Facilitate training directly related to the training quality system, including but not limited to data integrity, annual GMP concepts, Good Documentation PracticesReview and approve change management of training-related items in QTS, and serve as SQA for ERs and QARs within Quality SystemsServe as Training Quality System SME during customer and regulatory audits and prepare requested training completion and history reportsBASIC QUALIFICATIONSBachelor's Degree in Science, Engineering or related disciplineDemonstrated presentation skills to customers at various levels, with good written and verbal communication skillsCandidate is required to have a sound understanding of GMPs and various types of training documentation (e.g. PLS, Plateau, SOPs, User Guides, OJTs, curricula) with previous audit experienceClear track record of effective teamwork, collaboration and communication, with demonstrated ability to work in a cross-functional team environmentStrong organizational and prioritization skills to handle multiple items with changing deadlinesStrong critical thinking and analytical skills with h