Sr. Training & Development Associate

Job Summary: The Senior Training and Development Associate is responsible for designing, developing, and implementing training programs that support compliance with Current Good Manufacturing Practices (cGMP) and company policies. This role partners closely with Quality Assurance, Manufacturing, and other functional leaders, this role ensures training content is accurate, audit-ready, and aligned to both regulatory expectations and business needs. The ideal candidate has a solid background in instructional design, specifically within the pharmaceutical or regulated industry, with expertise in cGMP-focused training.

Key Responsibilities:

Training Design & Development

• Develop and implement comprehensive training programs focused on cGMP requirements to support Quality and Compliance across the organization.
• Collaborate with subject matter experts (SMEs) to conduct needs assessments, define learning objectives, and identify performance gaps in cGMP knowledge.
• Design, develop, and maintain instructional materials such as eLearning modules, training manuals, SOP guidelines, job aids, video scripts, and assessments to facilitate effective learning.
• Create engaging, learner-centered content using a variety of instructional methods, including instructor-led training (ILT), eLearning, blended learning, and microlearning.
• Regularly update training materials to reflect changes in regulatory guidelines, SOPs, and industry best practices.

Delivery & Compliance

• Conduct training sessions for new hires and existing employees, ensuring comprehension and adherence to cGMP standards.
• Collaborate with Quality Assurance to ensure cGMP training remains consistent with Aveva's SOPs and meets FDA, ISO, and other applicable regulatory body requirements.
• Support internal and external audits and inspections by preparing training documentation and demonstrating compliance with training requirements.
• Own the end-to-end training lifecycle — from needs assessment through content development, deployment, measurement, and continuous improvement.
• Maintain role-based curricula, job-specific training matrices, and training plans to ensure employees are assigned appropriate learning requirements.
• Monitor and trend Key Performance Indicators (KPIs) related to training compliance, overdue assignments, qualification status, and learning effectiveness, presenting findings and recommendations to management.
• Evaluate the effectiveness of training programs by collecting feedback, analyzing results, and making necessary adjustments to improve learning outcomes.

LMS Administration & Reporting

• Administer and optimize the Learning Management System (LMS) content, including curricula, training plans, learner assignments, and compliance tracking.

Qualifications:

• Bachelor's degree in Instructional Design, Education, Quality Management, or a related field. Equivalent or similar relevant work experience may be considered.
• Minimum 3–5 years of experience in training development, instructional design, or a related role within a cGMP-regulated industry, preferably pharmaceuticals or medical devices.
• Strong understanding of cGMP requirements, FDA and ISO regulatory guidelines, and compliance expectations within the pharmaceutical industry.
• Strong understanding of EQMS systems and LMS systems (preferably TrackWise/Salesforce)
• Familiarity with instructional design models (e.g., ADDIE, Kirkpatrick's Evaluation Model) and adult learning principles is preferred.
• Experience with eLearning authoring tools (e.g., Articulate Storyline, Adobe Captivate) is preferred.
• Excellent written and verbal communication skills with strong attention to detail.
• Ability to work independently and manage multiple projects with competing deadlines.

Skills:

• cGMP training development and regulatory compliance training
• eLearning and multimedia content creation
• LMS administration and training data analysis
• Instructional design

Working Conditions:

• Full-time position, based at Aveva Drug Delivery Systems - Miramar, FL Minimal travel required (occasional, e.g.,- 10%), primarily for inter-site training delivery.