Associate Director, QMS (Quality Management Systems) & CSA (Computer Software Assurance

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, QMS and CSA is responsible for leading the design, implementation, and continuous improvement of the company’s Quality Management System (QMS) and Computer Software Assurance (CSA) framework. This role ensures that quality systems, processes, and digital platforms are compliant with global GxP regulations and aligned with industry best practices.

The Associate Director will provide strategic and operational leadership for QMS processes (e.g., deviations, CAPA, change control, document control) and oversee CSA activities to ensure compliant validation and lifecycle management of GxP computerized systems. This individual will partner cross-functionally to support inspection readiness, digital transformation, and scalable quality operations.

Job Responsibilities:

QMS Leadership & Oversight

• Lead the implementation and maintenance of a scalable, phase-appropriate QMS across GxP functions.
• Oversee core QMS processes including deviations, CAPA, change control, document management, and quality risk management.
• Ensure QMS processes meet global regulatory requirements (FDA, EMA, ICH, etc.) and industry expectations.
• Monitor quality metrics and trends to drive proactive quality improvements and management visibility.

Computer Software Assurance (CSA) & Digital Quality Systems

• Establish and maintain CSA framework aligned with FDA CSA guidance and risk-based validation principles.
• Oversee validation lifecycle activities for GxP computerized systems (e.g., Veeva).
• Partner with IT and system owners to ensure systems are implemented, maintained, and enhanced in a compliant state.
• Drive adoption of risk-based validation approaches and ensure appropriate documentation and traceability.

Inspection Readiness & Compliance

• Ensure ongoing inspection readiness for QMS and computerized systems.
• Support regulatory inspections and internal audits related to QMS and CSA.
• Review audit findings, drive CAPAs, and ensure effective resolution and continuous improvement.

Process Development & Continuous Improvement

• Develop and maintain SOPs, work instructions, templates, and policies related to QMS and CSA.
• Identify and implement process improvements to enhance efficiency, compliance, and scalability.
• Support digital transformation initiatives and integration of quality systems.

Cross-Functional Leadership

• Partner with CMA, Technical Operations, Regulatory, Clinical Development Operations, and IT teams to ensure alignment on quality system requirements.
• Lead or mentor team members and contribute to building a strong quality culture.

Qualifications:

Education & Experience

• Bachelor’s degree in life sciences, engineering, or related discipline; advanced degree preferred.
• 8–12+ years of experience in Quality Assurance within GxP-regulated environments.
• 3–5+ years of experience managing QMS processes and/or computerized system validation/CSA.
• Experience supporting regulatory inspections (FDA, EMA, etc.).

Technical Expertise

• Strong knowledge of GxP regulations (GCP, GMP, GLP) and ICH guidelines.
• Deep understanding of QMS processes and lifecycle management.
• Experience with CSA or CSV (Computer System Validation) in a regulated environment.
• Familiarity with eQMS platforms (e.g., Veeva Vault) and other GxP systems.
• Knowledge of risk-based approaches to validation and quality system management.

Competencies

• Strategic thinker with strong execution skills.
• Excellent cross-functional collaboration and stakeholder management.
• Strong analytical, problem-solving, and risk assessment skills.
• Effective communicator with the ability to influence across all levels of the organization.
• Ability to manage multiple priorities in a fast-paced, evolving environment.

Preferred Qualifications

• Experience in clinical-stage biotech or pharmaceutical company.
• Certification (e.g., ASQ CQA, CSV/CSA-related certifications).
• Experience leading QMS implementations or major system deployments.

Travel Required:

Up to 10–20% travel 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 $186,000 - $225,000 . 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.

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