Manager, QA Learning and Development
About The Position
The Manager, Quality Assurance (QA) Learning & Development develops, governs, and continually improves training programs supporting Avid’s GMP operations, including Documentation, Batch Release, Quality Event Management, and Quality Systems Management. The role ensures GMP personnel are trained and qualified according to cGMP requirements, ALCOA+ data integrity principles, and site Quality Systems. The position partners with training leads in Manufacturing, QC, MSAT/Process Development, Facilities, EHS, and HR to establish a comprehensive, scalable learning strategy that strengthens workforce competency, supports compliance, and improves operational readiness across functions. It leads QA learning strategy and training governance, develops and delivers training, oversees learning management system (LMS) governance and records, supports operational readiness and audits, tracks training metrics, and provides functional leadership and coaching to trainers and site training leads. This is a full-time onsite position in Tustin, California. The stated schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., unless otherwise stated by the supervisor. The employee must be able to work overtime and/or weekends when necessary.
Requirements
- 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.
- 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.
- Strong project management, communication, coaching, leadership, conflict resolution, and change management skills.
- Strong presentation and facilitation skills.
- Ability to work overtime and/or weekends when necessary.
- Ability to perform regular sitting, standing, and walking, and occasional lifting of objects up to 25 pounds.
- Visual acuity, including close, distance, and color vision, is essential for the role.
Nice To Haves
- Familiarity with Veeva QMS.
- Experience using project management and related software.
- Proficiency with Smartsheet.
- Certified Professional in Talent Development (CPTD) or a comparable credential.
- Experience in a CDMO environment.
Responsibilities
- 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 QA departments.
- Define, maintain, and continuously improve training curricula, qualification paths, and skill matrices.
- Create 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, reflecting current processes, documentation expectations, and applicable FDA, EMA, and other regulatory standards.
- Serve as the site subject matter expert for the LMS, overseeing training records, curriculum updates, system governance, and compliance metrics.
- Ensure training reinforces Good Documentation Practices (GDP) and ALCOA+ principles.
- Monitor training completion, effectiveness, and inspection readiness, and escalate compliance gaps through established channels.
- Partner with QA and technical subject matter experts to prepare training 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.
- Create and maintain training dashboards tracking 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.
- 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.
Benefits
- Competitive compensation package including base salary and performance-based bonuses.
- Health, dental, and vision insurance.
- 401(k) matching.
- Paid time off.
- Career growth and development opportunities.
- Supportive and inclusive work environment.
- Reasonable accommodations are available to enable individuals with different abilities to perform effectively.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
