Quality Systems & GxP Training Lead

Actalent; Foster City (CA); Hybrid; USD 76,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

HSA

Transportation benefits

PTO

Job summary

Actalent in Foster City, CA, is seeking a Quality Systems Specialist to support the PDM and Quality organizations by designing risk-based, compliant training solutions. You will optimize curricula, translate learning strategy into inspection-ready deliverables, and collaborate with project managers to balance compliance and operational efficiency.

The role requires 6–8+ years in regulated environments with GxP training exposure and strong LMS knowledge.

Qualifications

• 6-8+ years in a regulated pharmaceutical, biotech, or medical device environment with direct GxP training or Quality Systems experience.
• Working knowledge of the pharmaceutical Quality System and GxP training requirements.
• Ability to exercise independent judgment on training impact and compliance-driven learning decisions.
• Proven experience applying risk-based thinking to training requirements while balancing regulatory expectations and operational needs.

Responsibilities

• Partner with SMEs, process owners, and leaders to assess training impact for governance procedures.
• Apply a risk-based approach to determine training requirements, audiences, and delivery methods.
• Assess and optimize training curricula and role-based assignments for alignment with responsibilities and quality expectations.
• Translate learning strategy into compliant training deliverables with project managers and stakeholders.
• Serve as Training Subject Matter Expert advising cross-functional partners.
• Analyze complex training impacts and propose practical, defensible solutions.
• Support design and execution of site or functional training programs meeting compliance goals.
• Develop, maintain, and govern training content, records, and metrics per policies and regulations.
• Support LMS administration and use training data for continuous improvement.
• Coordinate training activities within defined objectives and timelines.
• Identify opportunities to improve training efficiency and learner experience.
• Provide additional training and quality support as directed by management.

Skills

GxP training

Quality Systems

Risk-based thinking

LMS expertise

Data-driven decision-making

Cross-functional communication

Tools

LMS

Job description

Actalent in Foster City, CA, is seeking a Quality Systems Specialist to support the PDM and Quality organizations by designing risk-based, compliant training solutions. You will optimize curricula, translate learning strategy into inspection-ready deliverables, and collaborate with project managers to balance compliance and operational efficiency.

The role requires 6–8+ years in regulated environments with GxP training exposure and strong LMS knowledge.