Manager, QA Learning and Development

Your Role

The Manager, Quality Assurance (QA) Learning & Development is responsible for developing, governing, and continuously improving training programs that support Avid's GMP operations, including Documentation, Batch Release, Quality Event Management and Quality Systems Management. This role ensures that GMP personnel are trained and qualified in accordance with cGMP requirements, ALCOA+ data integrity principles, and site Quality Systems. This position partners closely with training leads in Manufacturing, QC, MSAT/Process Development, Facilities, EHS, and HR to develop a comprehensive and scalable learning strategy that strengthens workforce competency, supports compliance, and improves operational readiness across functions.

Key Responsibilities

Learning Strategy & Governance

• Partner with site training leads to maintain global training and LMS governance.
• Lead company-wide learning initiatives that strengthen quality, employee engagement, and consistent cGMP practices.
• Develop and oversee the QA learning strategy supporting QA operations.
• Conduct learning needs assessments, skills-gap analyses, and competency evaluations across all QA departments.
• Define, maintain, and continuously improve training curricula, qualification paths, and skill matrices.

Training Program Development & Delivery

• Create engaging instructor-led and e-learning materials.
• Develop SOP based learning modules, technical process training, and hands on OJT and SOJT qualification programs.
• Deliver training through classroom sessions, floor-based coaching, and virtual platforms.
• Develop and manage cGMP-compliant quality assurance training for drug substance manufacturing, ensuring that content reflects current processes, documentation expectations, and applicable FDA, EMA, and other regulatory standards.

Training Compliance & Documentation Standards

• Serve as the site subject matter expert for the Learning Management System, overseeing training records, curriculum updates, system governance, and compliance metrics.
• Ensure all training reinforces Good Documentation Practices (GDP) and ALCOA+ principles.
• Monitor training completion, effectiveness, and inspection readiness, and escalate identified compliance gaps through established channels.

Operational Support & Cross-Functional Collaboration

• Partner with QA and technical subject matter experts to ensure training readiness for new equipment, processes, product introductions, and technology transfers.
• Provide on-the-floor coaching and support for SOJT/OJT qualification processes.
• Support internal and external audits as the QA L&D representative.
• Collaborate with HR and operational leaders to standardize onboarding, cross-training, and development pathways.

Metrics, Reporting & Continuous Improvement

• Create and maintain training dashboards that track compliance, documentation performance, correction trends, qualification status, and training effectiveness.
• Analyze performance data to identify trends, determine root causes, reduce documentation errors, and improve process consistency.

Leadership & People Development

• Provide functional leadership, coaching, and guidance to trainers, subject matter experts, and site training leads.
• Promote a culture of learning, accountability, and operational discipline.
• Identify workforce competency gaps and partner with leaders to develop targeted development plans.

Minimum Qualifications

• Bachelor's degree in life sciences, biotechnology, instructional design, education, organizational development, or a related field.
• At least 5 years of quality assurance or training experience in biopharmaceutical manufacturing, preferably in a CDMO environment, with demonstrated expertise in quality systems and cGMP compliance, including GDP and ALCOA+ requirements.
• Demonstrated experience designing, implementing, and evaluating technical or compliance-based training programs.
• Proficiency in instructional design methodologies, including ADDIE and SAM, and e-learning authoring tools.
• Familiarity with Veeva QMS is preferred.
• Strong project management, communication, coaching, leadership, conflict resolution, and change management skills.
• Strong presentation and facilitation skills.

Preferred Qualifications

• Experience using Project Management and related software.
• Proficiency with Smartsheet is preferred.
• Certified Professional in Talent Development (CPTD) or a comparable credential is preferred.