Associate Director, GxP Training

About Us:

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.

Position Summary:

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.

Job Responsibilities: 

GxP Training Strategy & Program Leadership

• 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

Training Operations, Compliance & Systems

• 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

Training Effectiveness & Quality Performance Integration

• 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

Quality Planning & Performance Support

• 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

Inspection Readiness & Continuous Improvement

• 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

Cross-Functional Leadership & Governance

• 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

Qualifications:

• 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

Technical Expertise

• 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

Competencies

• 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

Preferred Qualifications

• 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

Travel Required:

Up to 25% may be required.

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $170,000 - $215,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Structure Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.

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