Director, Quality Systems & Compliance

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 has completed an initial public offering (IPO) in February of 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
Lead the development, implementation, and continual enhancement of the organization’s Quality Management System (QMS). Ensure compliance with relevant industry standards and regulations (e.g., ISO 9001, ISO 13485, FDA 21 CFR Part 210, 211 and 820). The role supports the electronic document management system, coordinates and executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop and execute QMS strategies aligned with business goals.


• Responsible for the management of the eQMS including workflow configuration and upgrades as needed, collaborating cross-functionally to identify, define and implement process improvement opportunities for enhanced workflows.


• Serve as the SME for QMS, providing guidance and training on systems, processes, quality events, and driving timely completion of records


• Act as the Quality Business Process Owner for eQMS processes, including Quality Risk Management, Data Integrity, and Change Control.


• Oversee & manage QMS processes, including Nonconformance/Quality Events, CAPAs, and Complaints, and review and approve related procedures.


• Continually assess and manage eQMS processes to ensure compliance with regulatory guidelines and industry standards. Oversee workflow configuration and upgrades and collaborate cross-functionally to implement process improvements.


• Review and approve procedures in support of eQMS.


• Develop, implement, and maintain the global CSV global strategy aligned with company goals, regulatory expectations, and industry best practices.


• Serve as regulatory liaison for cross-functional departments, inspections, and audit response.


• Oversee the development, implementation and maintenance of a comprehensive GxP training strategy aligned with regulatory requirements.


• Support the development and presentation of eQMS training materials to ensure ongoing education on core quality procedures and industry standards.


• Implement preventive and corrective actions across the organization.


• Build QMS awareness and drive training across teams.


• Define and analyze trends and report key performance indicators (KPIs) for QMR meetings and present Quality Metrics to support Quality Management Reviews


• Lead and drive improvement opportunities to enhance product quality and process effectiveness throughout the eQMS lifecycle.


• Lead and mentor QMS and QA/Compliance teams.


• Develop, mentor team members and manage performance reviews.


• Foster a standardized quality culture across operational areas and identify opportunities for continuous improvement.

REQUIREMENTS
Education:
Bachelor’s or Master’s degree in engineering, Life Sciences or related field is required.

Experience:

• 10+ years in quality/regulatory leadership within biopharma, ideally with small molecule experience


• Specific knowledge of 21 CFR Parts 11 / 210 / 211, EudraLex Volume 4, WHO regulations regarding GMPs and GDPs


• Strong understanding of risk assessment and risk management fundamentals/tools


• Proven experience influencing senior leadership and working across functional areas


• Excellent communication, analytical, and problem-solving capabilities


• Inspection management experience preferred

Travel:

Available to travel if/when needed

The target salary range for this full-time role is $205,000 - $258,500 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.