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

Structure Therapeutics•South San Francisco, CA

9d•$186,000 - $225,000•Onsite

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.

Requirements

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.).
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.
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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.