Training Program Manager, QA

Summary

The Training Program Manager, QA reporting to the Senior Director, QA primary role will be to manage and build a training program for the Company. This person will be highly organized and enjoy teaching others and possess and demonstrate a customer service approach and perspective.

Principal Duties/Responsibilities:

• Set up site training program (including Onboarding program: Quality, Safety, Documentation, etc.), work with departments to establish their training programs, including interface with SOP generation/revision processes

• Manages and grows the QA Training team responsible for administration of the cGMP

• Training program to include curricula organization and deployment, oversight of organizational training status in both local and enterprise learning management systems (LMS) and providing real-time training consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.

• Collaborates closely with all department management at the AIRM location to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.

• Partner with functional areas to conduct monitoring of training compliance status, efficiency checks, and trend results.

• Responsible for ensuring training on documentation and training related processes and procedures are performed according to defined expectations.

• Oversees the QA Training function. Ensures adequate systems are in place to achieve personnel training and qualification compliance with GMP quality expectations.

• Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.

• Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.

Qualifications:

• BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.

• Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.

• Fluency in GMP training, document administration, and data integrity principles.

• Working knowledge of predicate regulations and industry consensus standards, including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.

• Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.

• Advanced proficiency in MS Word, Excel, and PowerPoint.

Work Environment:

The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.