MUST HAVE : Manager IS wanting someone with QA background within Document Control systems,EDMS systems; administering created SOPs into the systems and kicking it out through the LMS system for training. Indivior is using Veeva Quality Docs but open to tradeoffs. They currently don't have a Doc control team to partner with the consultant and admin the documents; so they will need the consultant to own the full process.
Ideally 8 years of LMS systems experience – creating curriculum.
Focus on GMP experience, nice to have GxP experience as well.
The Global Training Manager is part of the global Quality and Supply organization, supporting and working in partnership with all GxP functions, I&C, HR and IT. This is a key global project role in creating strategic plans with cross functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System related to Training. This role reports to the Head of Global Quality Systems & Operational Excellence.
Leader in industry Training (process and system), ensure that Global Training is effectively designed, standardized, simplified, improved, and communicated to follow all applicable internal and external regulations and standards.
Experience delivering instruction across multiple platforms, managing people and group facilitation/coaching.
Cross-functional influence to create strategic plans to ensure establishment and lifecycle management of a compliant Training program.
Strong and confident negotiator who understands optics and soft skills within a corporate environment.
Global role that works across all functions with confidence and professionalism.
Occasional travel to meet the needs of the role.
Act as a change agent using continuous improvement methodology and deployment across global functions. This includes Lean Six-Sigma methodologies and project management.
Success will be shown with the delivery of global Quality Compliance orientation, a streamlined Training Program, updated process documentation and development of standardized role based global curricula (training plans).
Daily Responsibilities
Provide direct oversight and influence for the Training processes (inside and outside the Quality function) and work with stakeholders to identify and rectify compliance gaps and improvements.
Development of formal improvement plan to the Training process based on root cause analysis, data driven evidence and use of appropriate Lean methodology and tools.
Provide thought leadership and influence for functional management to champion a standardized Training approach and curricula/plan within their functions.
Identify and report appropriate process & IT system metrics and trends to functional heads to drive compliance. Able to interpret metrics and trends to identify areas of improvement.
Assist, and/or provide guidance to functional training LMS super user teams in local area(s) where needed.
Manage delivery of orientation training for new hires and the curriculum requirements for regular staff through the utilization of the LMS capabilities.
Accountable for the performance of the Training process end to end.
Act as IT learning system (LMS) super user/administrator and support and advise on IT system changes when required.
Write GxP documentation (e.g., Policies, SOPs, Work Instructions), process maps, training packages with excellent technical writing skills and clarity.
Generate effective means of training for all stakeholders and SMEs for the process.
Soft Skills
Excellent team player, able to work across boundaries to accomplish goals set.
Excellent interpersonal and communication skills, ability to communicate clearly to peers and senior management.
Background
Bachelor of Science degree in Education and/or in a life science or engineering discipline is desirable.
Knowledge of the pharmaceutical industry and Quality Systems or experience working within a regulated and/or GxP discipline (cGMP, GPV, GCLP, GDP) is advantageous.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Human Resources
Industries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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