Compliance Training Manager

Employer
Novartis
Location
San Carlos, CA
Posted
Oct 18, 2018
Ref
248610BR
Required Education
Bachelors Degree
Position Type
Full time

Job Purpose

The Training Lead will be responsible for the management of training including compliance with the Quality Management System and GXP and training required by HSE, HR, Facilities, and other support functions.

Basic Major Activities

  • To ensure all personnel are appropriately trained (and re-trained as required) in accordance with position requirements.
  • Set individual curricula for both mandatory (compliance related) trainings and developmental trainings.
  • In conjunction with line units and support functions, develop and maintain training plans aligned to job specifications for new personnel and contractors and ongoing for permanent personnel.
  • Take a proactive role for continuous improvement and lead training improvement projects
  • Develop the content and format of training materials for the Good Manufacturing Practices training program.
  • Responsible for group and individual training sessions, including scheduling, training material/media development, presentation and record keeping. 
  • Deliver trainings for the key GMP requirements to all levels of personnel across the organization and monitor the quality of training delivery
  • Ownership and maintenance of a compliant Training subsystem to support the Site Quality and Development
  • Ensure all staff are trained in the principles of GMP
  • Develop and provide data on Training KPIs
  • Maintain official Manufacturing GMP department training curriculum in centralized location, update and organize on a routine basis with input from supervisors.
  • Generate system for tracking Manufacturing GMP training status against current procedures (provide a % trained status update monthly report, maintain training manuals
  • Design and deliver a program of routine auditing of departmental training files to verify the local management of individual training files is carried out in a compliant manner.
  • Respond to training related audit observations and close out CAPAs in a timely manner.
  • Audit training binders.
  • Represent the site training systems during audits.
  • Provide guidance to and ensure compliance in GMP training practices and documentation.
  • Interface with all GMP groups to provide support and oversight of training compliance. 
  • Deliver select standard corporate training packages
  • Support the HR and HSE department in the development, implementation and updates of the training materials and programs. 
  • Develop training curriculum for employee trainings.

Key Performance Indicators

  • Compliant outcomes during internal and external GXP audits and Health Authority inspections.
  • Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
  • Feedback from other team members/leaders and stakeholders
  • Contribute to annual individual and department objectives.

Job Dimensions

Number of associates:  None directly at this time; possibly in the future

Financial responsibility: None directly; responsible for department allocations for training function

Impact on the organization: Must ensure all associates are trained appropriately in the GXPs and related job skills required to perform their duties effectively. Also must maintain the trainings to assure compliance to GXPs and training SOPs. Serve as the expert on training related issues.

Ideal Background

Education: Bachelors degree or equivalent experience may be accepted.

Languages: English (oral and written) required.

Experience/Professional requirement: 

  • A minimum of 10 years of training or educational experience
  • A minimum of 8 years of experience in GXP manufacturing environment (manufacturing or QA)
  • Knowledge of an electronic Learning Management System (LMS) is desirable.
  • Excellent written, verbal and presentation skills
  • Ability to present analysis in a clear and compelling manner
  • Ability to work independently with little supervision in day to day tasks
  • Excellent sense of accountability, team spirit, and result orientation