The QA Compliance Training Manager reports to the Associate Director of Site Compliance and is responsible for creating, implementing and monitoring training programs that include but are not limited to Competency Based Technical and cGMP (Current Good Manufacturing Practices). The Training Manager position is a hands-on position that requires daily support of the SABA LMS (Leaning Management System) Training Software and active participation in development and delivery of SOP’s, Ethics and Code of Conduct, EHS, and ongoing cGMP training. This position supports site audits and site metrics preparation and assessment. Effective business partnering to assess individual departments’ training needs is essential.
Works cross-functionally with department heads and managers to develop individual training programs that meet identified skill gaps; develop job specific training matrices and core competencies for each job function
Facilitate proper utilization of the site’s Learning Management Software; assessing, updating, and maintaining appropriate SOP’s, Ethics, GMP and EHS materials and track department and individual progress
Partner with Human Resources to ensure all new hires receive Ethics and Code of Conduct training in a timely manner post start date
Maintains SABA/LMS records, runs reports, provides training to the site on how to effectively use SABA to document their training requirements.
Performs periodic review of training matrices with department heads and managers
Develops, prepares and delivers both general and specific topic cGMP training for the site in accordance with regulatory requirements and with procedures.
Develops specific training presentations in conjunction with identified training gaps.
Monitors evolving regulations, standards and government agency activities, interprets relevant information and takes appropriate actions to inform stakeholders and revise procedures as necessary.
Develops, prepares and delivers “Train the Trainer” training to employees identified by department management as local trainers. Assists satellite trainers in preparation and approval of training materials.
Acts as the site SME for Training during audits and provides requested training materials to support audits.
Responsible for oversight and control of all training records.
Monitors effectiveness of training program based on input from site management and quality metrics related to human error as well as other performance indicators deemed applicable.
Collects, analyzes and prepares training metrics and is prepared to present and discuss metrics.
Assist in meeting departmental goals and special projects as needed.
Other duties as assigned.
Bachelor's Degree from an accredited college or university in Education, Communication or related discipline plus a minimum of five years training experience- Masters Degree plus a 3+ years training experience.
5+ years’ related experience as a Trainer in pharmaceutical, biotech, or a CMO; QA/Compliance background with some teaching experience is also acceptable
Ability to build solid cross-functional relationships.
Experience in “train the trainer” training.
Knowledge of curriculum design (classroom).
Demonstrated ability to select, organize, lead, participate and facilitate a team to produce results.
Ability to multi-task and handle a number of projects simultaneously in a fast paced environment.
Ability to represent the Training Department to other departments, to customers and to regulatory agencies.
Proficient in the use of MS Office applications (Excel, Word, Powerpoint).
Accurate – ability to perform work accurately and thoroughly.
Communication (Oral/Written) – Ability to communicate effectively in and oral and written form.
Problem Solving – Ability to find a solution or deal proactively with work related problems.
Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers. Strong interpersonal skills with a strong focus on customer service.
Confidentiality – Ability to work with and keep sensitive information confidential.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 20 pounds occasionally. Generally work is performed in an office environment.
Lupin Somerset is an operating division of Lupin, which is among the top performing global generic pharmaceutical companies. Lupin Somerset is located in central New Jersey and is the first manufacturing facility in the United States for Lupin. There are approximately 400 employees in the Somerset, New Jersey division working in all functional areas including Research & Development, Manufacturing..., Packaging, Warehouse, Finance and Accounting, Human Resources, Regulatory Affairs, Information Technology, Quality Control, Compliance, and Quality Assurance.