Manager, QA Learning and Development

Description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

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.

Position Type/Expected Hours of Work:

This role is a full-time onsite position in Tustin, CA. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $106,931 - $133,663 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.