Pfizer GMP Training Mgr/TL in Kalamazoo, Michigan
Accountable for the development, delivery, assessment, continuous improvement and maintenance of the Kalamazoo Training Quality System and supporting programs, documentation, and courses and site orientation program
Manages the GMP Training and Document Change Control personnel to ensure compliance to global, site, regulatory, and customer requirements, policies, processes and standards
Serves as the Site Training Lead with matrix responsibility for other Business Area Training Leaders to ensure alignment with site training initiatives and compliance requirements
Accountable 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 processes
Interacts 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 initiatives.
Provide leadership and coaching to direct report colleagues and contractors, including setting annual objectives and developing and maintain annual training and records retention budgets
Serve as the site point of contact for Global Training initiatives and coordination of cross-site orientation
Establish, 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. 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 practices
Establish and maintain relationships with record retention suppliers
Represent Kalamazoo within the Pfizer learning network and CICR community of practice
Deliver / Facilitate training directly related to the training quality system, including but not limited to data integrity, annual GMP concepts, Good Documentation Practices
Review and approve change management of training-related items in QTS, and serve as SQA for ERs and QARs within Quality Systems
Serve as Training Quality System SME during customer and regulatory audits and prepare requested training completion and history reports
Bachelor's Degree in Science, Engineering or related discipline
Minimum of 3 years related experience
Demonstrated presentation skills to customers at various levels, with good written and verbal communication skills
Candidate 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 experience
Clear track record of effective teamwork, collaboration and communication, with demonstrated ability to work in a cross-functional team environment
Strong organizational and prioritization skills to handle multiple items with changing deadlines
Strong critical thinking and analytical skills with high attention to detail
Ability to manage change and deal with ambiguity
Proficiency with QTS for change management, commitment tracking, and manufacturing investigations
Proficiency with Microsoft Outlook, Excel, PowerPoint, Project
QA pharmaceutical experience.
Demonstrated use of instructional design principles in designing and implementing training programs
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to flex work schedule to provide training at end or beginning of off-shifts, or to accommodate regulatory audit schedules.
Other Job Details:
Last Date to Apply: May 21st , 2020
Eligible for Employee Referral Bonus
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Quality Assurance and Control