Kforce has a client that is seeking a Senior Manager, GxP Training Quality and Compliance in Cambridge, MA.
The Senior Manager will be responsible for overall development, management, and administration of BDTx GxP training program/process to ensure state of control and compliance readiness. In addition, this role will be responsible for the analysis, development, delivery, and completion of various training related activities associated with the implementation of a new GxP electronic Quality Management System (eQMS). The Senior Manager will collaborate cross functionally with core project team members, GxP stakeholders and external business partners to ensure process is current, standardized, in a state of compliance and aligned with industry best practices.
* A minimum of a Bachelor's degree is required
* Minimum 5 to 8 years of experience in QA Training management or educational development in a corporate, scientific and/or manufacturing environment within the pharmaceutical, biotechnology industry
* Proficient in an electronic Learning Management System (eLMS)
* Experience creating and implementing GxP training programs, experience with implementation of eLMS is a plus
* Familiarity with training requirements for GxP quality systems, FDA, and other Health authority requirements
* Must possess a high level of attention to detail
* Strong computer, organizational, and compliance skills
* Ability to work effectively on multiple projects simultaneously with minimum supervision
* Strong interpersonal and communication skills
* Expert level management of training projects with multiple subject matter experts
* Experience designing SCORM files required preferably using Captivate Articulate software
* Excellent presentation skills and a proven track record of delivering successful training and presentations
* Ability to influence without direct authority
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.