Quality System and Compliance Specialist

• Identify, design, present and evaluate training and development needs supporting strategic business objectives.
• Apply the adult learning model, including needs assessment, design, delivery and evaluation.
• Lead technical training projects according to agendas, target plans, specifications and timelines.
• Present technical training project proposals to senior management.
• Design and deliver innovative quality and GXP training programs, including templates, job aids, assessments and checklists.
• Identify internal and external resources and maintain professional customer relationships.
• Create training modules independently or with subject matter experts.
• Deliver organization-wide curricula supporting HES, SAP and cGXP objectives.
• Provide compliance oversight for curriculum and training procedures.
• Lead technical training activities and support trainer selection, coaching, technical training and facilitation development.
• Design and develop instructor-led, computer-based, web-based and e-learning training.
• Manage training from initial planning through final summary, including costs and lessons learned.
• Coordinate and facilitate orientation for new employees and contractors.
• Communicate ongoing technical training information to the site.
• Update training modules based on business-unit and regulatory needs.
• Consult on technical training needs and track training effectiveness and performance improvement.
• Deliver results to stakeholders to support continuous improvement.

Requirements

• Minimum BS/BA degree and 3-5 years’ relevant training experience in a regulated environment, or equivalent combination of education and experience.
• Minimum four years’ training experience in the development, design and implementation of technical training courses.
• Strong technical knowledge in the pharmaceutical industry.
• Relevant training experience within the past 5 years.
• Proficiency with word processing, graphics programs, databases, presentation delivery programs, video, web-based CBT and e-learning.
• Demonstrated high levels of values and integrity.
• Ability to maintain positive relationships internally and externally.
• Ability to work independently and in a team.
• Strong oral and written communication skills and good interpersonal skills.
• Excellent computer skills with MS Office and Adobe Acrobat.
• Bilingual French and English preferred.

Core Competencies

Demonstrates expertise in designing and delivering technical training programs within the pharmaceutical industry, utilizing adult learning principles and compliance oversight. Proficient in managing training projects from planning to execution, ensuring alignment with strategic business objectives.

Highest-signal resume keywords

• Technical Training Development
• Pharmaceutical Industry Knowledge
• Adult Learning Model Application
• Curriculum Design and Delivery
• Bilingual French and English

ATS Optimization Keywords

Hard Skills

• Training Needs Assessment
• Curriculum Development
• E-Learning Design
• Instructor-Led Training
• Computer-Based Training
• Training Evaluation
• Compliance Oversight
• Project Management
• Performance Improvement Tracking
• Technical Proposal Presentation

Soft Skills

• Strong Communication Skills
• Interpersonal Skills
• Team Collaboration
• Relationship Management
• Integrity and Values

Industry Keywords

• Regulated Environment
• GXP
• HES
• CGXP
• Training Effectiveness

Tools & Technologies

• MS Office
• Adobe Acrobat
• Graphics Programs
• Databases
• Presentation Delivery Programs
• Web-Based CBT