QA Training Manager (2008042)

Description



In this new position, you will work with organization leadership and staff to assess training needs and recommend appropriate actions to ensure that Lonza Biologics' Hopkinton location is compliant with required regulatory standards.

Reponsibilities will include: Set up and manage Training Management System to ensure all QA-related training is recorded to ensure compliance to relevant GMP standards. Work closely with department representatives and selected subject matter experts to assess gaps in current training programs. Upgrade, design and manage the implementation of programs to meet the training needs of the client groups. - Co-ordinate and monitor the cGMP orientation program and the design and implementation of an ongoing cGMP awareness training program. Develop and maintain Standard Operating Procedures which describe the training system, meet the training policy guidelines and conform to regulatory practices. Monitor and evaluate the effectiveness of the implemented actions and ensure that all training programs are continuously improved to set the highest quality standards.  Investigate citations or unsuccessful results and troubleshoot, creating/implementing remedial action(s) to prevent reoccurrences.  Deliver presentations and classroom instruction (such as train-the-trainer)in support of training initiatives. Negotiate with internal and external resources to obtain materials necessary to support the development and/or delivery of training programs. Recommend approaches to training needs to site leadership and participate in the implementation of the decisions. Develop and implement procedures to control training costs, evaluate the effectiveness of training and make decisions on purchases, vendors and consultants related to the responsibilities. Develop and implement systems and procedures to record all training carried out, ensuring compliance with regulatory authorities in this regard. Conduct routine internal GMP audits of departmental training compliance and report results to site management. ~cb~Required Skills

BS in scientific discipline. Post graduate degree, in a science or educational discipline preferred by not required.Proven track record of managing, developing and leading a training department in a cGMP environment. Comprehensive knowledge of GMP and regulatory requirements for the biopharmaceutical industry.8-10 years in Pharmaceutical, Biotechnology or related industry with at least 3 years in Training Management including evaluting, implementing and overseeing both inside and external training programs, working with training tracking database and web based training technology, presenting group training and one to one training. SAP training/tracking preferred.Self-starter; motivated, enthusiastic communicator with a desire to continuously improve systems and performance. Able to communicate appropriately with a range of people from a variety of backgrounds. Able to work without close supervision and help to set own performance targets. Able to manage time and resources to meet the aims of the company. Must be available for occasional work out of standard working hours. Required ExperienceLonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life -science industries. With over 40 locations around the world, Lonza offers products and services that span the product development process -- from research through final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Are You Interested? Please apply at www.lonza.com