GxP Quality Systems & Training Specialist

Actalent; United States; Hybrid; USD 76,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO / Vacation

Life Insurance (Voluntary)

Job summary

Actalent is seeking a Quality Systems Specialist to support the PDM and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and aligning curricula with job roles and Quality System expectations. This hybrid Foster City, CA role requires on-site presence on Tue, Wed, and Thu.

The position involves partnering with SMEs, applying a risk-based approach to determine training needs, and optimizing curricula, while supporting LMS, records, and

Qualifications

• 6-8+ years of experience in a regulated pharmaceutical, biotech, or medical device environment, with direct experience in GxP training, Quality Systems, or compliance.
• Working knowledge of the pharmaceutical Quality System and GxP training requirements.
• Demonstrated 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.
• High attention to detail with the ability to anticipate downstream impacts to curricula, learners, and compliance.
• Effective communicator with the ability to influence and challenge stakeholders constructively using data-driven rationale.
• Working knowledge of LMS functionality, training data, and metrics.

Responsibilities

• Assess training impact for governance procedures with SMEs and Leaders.
• Apply risk-based approach to determine training requirements and delivery methods.
• Optimize curricula and role-based assignments to align with responsibilities.
• Translate learning strategy into compliant training deliverables with project managers.
• Serve as Training Subject Matter Expert advising on compliant training approaches.
• Analyze cross-functional training impacts and propose defensible solutions.
• Support LMS administration and use training data for continuous improvement.

Skills

GxP training

Quality Systems

LMS knowledge

Risk-based thinking

Data-driven decisions

Cross-functional collaboration

Tools

LMS

Job description

Actalent is seeking a Quality Systems Specialist to support the PDM and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and aligning curricula with job roles and Quality System expectations. This hybrid Foster City, CA role requires on-site presence on Tue, Wed, and Thu.

The position involves partnering with SMEs, applying a risk-based approach to determine training needs, and optimizing curricula, while supporting LMS, records, and