Associate Director, GxP Training

Structure Therapeutics•South San Francisco, CA

15h•Hybrid

About The Position

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Reporting to the Director, Quality Systems & Compliance, the Associate Director, GxP Training is responsible for leading the development, implementation, and continuous improvement of the company’s GxP training and learning programs. This role ensures that training programs effectively build organizational capability, support compliance with global GxP regulations, and enable quality performance across the organization. The Associate Director will integrate training strategy with quality planning and performance data to proactively address risks, improve effectiveness, and support a culture of continuous improvement. This individual will partner cross-functionally to align training programs with quality objectives, business priorities, and regulatory expectations, while contributing to quality planning activities including metrics, management review (QMR), and inspection readiness.

Requirements

Bachelor’s degree in life sciences, engineering, business, or related discipline; advanced degree preferred
10+ years of experience in GxP-regulated environments, with a focus on training, quality systems, or organizational capability development
Demonstrated experience leading GxP training programs and learning strategies
Experience supporting regulatory inspections and audits
Strong knowledge of global GxP regulations (GCP, GMP, GLP) and ICH guidelines
Experience managing GxP training programs and Learning Management Systems (e.g., Veeva Vault)
Experience with quality metrics, QMR processes, and performance trending
Familiarity with QMS processes (deviations, CAPA, change control, audits)
Knowledge of data-driven decision-making and risk-based approaches
Strong performance consulting and problem-solving skills
Strategic thinker with the ability to translate data into actionable insights
Excellent cross-functional collaboration and stakeholder management
Effective communicator with the ability to influence at all levels
Ability to manage multiple priorities in a fast-paced, evolving environment

Nice To Haves

Experience in clinical-stage biotech or pharmaceutical company
Experience building or transforming training programs, quality planning, or QMR
Certification in Quality (e.g., ASQ CQA) or Learning & Development
Project Management Professional (PMP) Certification

Responsibilities

Lead the design, development, and continuous improvement of a comprehensive GxP training program across GxP functions
Oversee the end-to-end training lifecycle, including needs assessment, training design, delivery, and effectiveness evaluation
Develop and implement role-based curricula, onboarding programs, and continuing education aligned with regulatory and business needs
Ensure training programs are risk-based and aligned with quality priorities, focusing on high-impact areas
Drive a shift from compliance-based training to performance-based capability development
Ensure training compliance with global GxP regulations and internal policies, including inspection readiness
Oversee training records, documentation, and LMS management (e.g., Veeva Vault)
Monitor and report training KPIs (e.g., completion, effectiveness, timeliness) and identify risks or gaps
Serve as SME for training during regulatory inspections and audits
Analyze training effectiveness data and link outcomes to quality performance trends (e.g., deviations, CAPAs, audit findings)
Identify whether quality issues are driven by capability, process, or system gaps, and recommend appropriate interventions
Partner with Quality and functional teams to implement targeted learning solutions addressing root causes
Utilize data-driven insights to continuously refine training strategy and improve organizational performance
Support the development and implementation of quality planning processes, including quality objectives and KPIs
Lead coordination of the Quality Management Review (QMR) process, synthesizing quality performance data to drive risk identification, trend analysis, and informed leadership decision-making
Develop and deliver quality performance reports and dashboards for Executive Leadership Team (ELT) to communicate key trends, escalate risks, and provide visibility into quality system effectiveness
Track and report on progress against quality objectives, goals, and strategic initiatives, ensuring accountability and transparency across the organization
Collaborate with cross-functional stakeholders to establish and maintain consistent metric definitions, reporting standards, and data integrity
Support the identification and prioritization of quality risks and continuous improvement initiatives based on data-driven insights
Ensure training programs support ongoing inspection readiness and regulatory compliance
Identify and address systemic gaps related to training, quality performance, and process execution
Drive continuous improvement initiatives to enhance training effectiveness, efficiency, and scalability
Partner with Clinical, Regulatory, Technical Operations, and other GxP functions to align quality objectives, metrics, and training strategies
Facilitate cross-functional discussions to resolve metric inconsistencies and performance gaps
Influence stakeholders to drive accountability for quality performance and continuous improvement
Contribute to fostering a proactive, performance-driven quality culture