Manager, QA Learning and Development

Avid Bioservices•Tustin, CA

11d•Onsite

About The Position

The Manager, Quality Assurance (QA) Learning & Development develops, governs, and continuously improves training programs that support 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. It partners with training leads across Manufacturing, QC, MSAT/Process Development, Facilities, EHS, and HR to develop a scalable learning strategy that strengthens workforce competency, supports compliance, and improves operational readiness. The manager oversees QA learning strategy and training governance, assesses learning needs and competencies, develops curricula and qualification pathways, and creates and delivers instructor-led, e-learning, and hands-on training. As the site subject matter expert for the Learning Management System, the role governs training records, curricula, and compliance metrics; monitors training effectiveness and inspection readiness; and supports audits, operational changes, onboarding, and cross-training. The position also provides functional leadership to trainers and site training leads and uses training and quality data to identify trends and improve performance. This is a full-time onsite role in Tustin, California. The regular 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. The role includes sitting, standing, and walking, occasional lifting up to 25 pounds, and possible occasional exposure to electrical shocks, toxic chemicals, vibrations, or loud noise. Close, distance, and color vision are essential to the role; reasonable accommodations are available.

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; CDMO experience is preferred.
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 onsite in Tustin, California, Monday through Friday, 8:00 a.m. to 5:00 p.m., and work overtime and/or weekends when necessary.
Ability to perform regular sitting, standing, and walking, and occasional lifting of objects up to 25 pounds.
Close, distance, and color vision needed 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 Learning Management System 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, 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 QA training for drug substance manufacturing that reflects current processes, documentation expectations, and applicable regulatory standards.
Oversee the LMS, including training records, curriculum updates, system governance, and compliance metrics.
Ensure training reinforces Good Documentation Practices 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 support 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 Learning and Development representative.
Collaborate with HR and operational leaders to standardize onboarding, cross-training, and development pathways.
Create and maintain dashboards tracking compliance, documentation performance, correction trends, qualification status, and training effectiveness.
Analyze performance data to identify trends and 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 on targeted development plans.