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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. #LIHybrid

POSITION SUMMARY
The Sr. Director, GMP Quality Assurance provide quality oversight of Contract Development & Manufacturing Organizations (CDMOs) involved in the production drug substance, drug product, and finished drug product, on behalf of Structure Therapeutics, to supply clinical trials and future commercial product. Further, this individual will collaborate with internal and external parties to promote and deliver compliant Quality outcomes by working closely with CDMOs, Manufacturing, Analytical Development & Quality Control, Regulatory, Quality Management Systems, and Clinical Trial Material Management to maintain clinical drug product supply. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day). If remote, you will be required to work in the SSF office one week/month.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide quality oversight of the manufacturing, testing, and release of DS and DP at CDMOs and contract testing laboratories
• Provide GMP guidance to CDMOs and Structure Technical Operations/ CMC teams
• Represent Quality and quality activities from the CDMO site on Structure project teams
• Provide Quality support of CDMO site activities (e.g. Tech Transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
• Conduct reviews and approvals (pre- and post-execution) of Master Batch Records (MBRs) and any associated supporting documentation, (such as stability and validation documentation, generation/updating of compliance dossiers etc.), to support lot disposition internally and/or prior to final assessment by a Qualified Person (QP) as applicable
• Review and approve Certificate of Testing, Certificates of Analysis, technical protocols and reports for clinical manufacturing process development, and QC assay qualification/validation
• Serve as the main Quality contact for deviations and out-of-specification (OOS) results; initiate CAPA processes and investigate the root cause and ensure timely closure of CAPA; ensure all deviation, OOS result, and CAPA records are accurate, complete, and auditable; and compile and analyze the deviation, OOS, and CAPA data for future improvement
• Ensure rapid communication of Quality issues, including issues of significant deviations with project/products, to business partners and senior management
• In collaboration with other QA team members,
  • Build and maintain the Quality processes needed to support Quality oversight of Technical Operations deliverables, including but not limited to supplier management, tech transfer, production, packaging, labeling, lot disposition, change control, and deviations, while ensuring all deliverables are inspection ready and compliant with applicable regulatory requirements
  • Establish, monitor metrics, reporting, and support cross-functional review forums, including the Quality Management Review process
  • Support activities related to key Quality Management System (QMS) systems, processes, tools, training, programs, and governance, including the eQMS, computer system validation, Quality management review (QMR), supplier Quality management (SQM), internal and external audit, inspection readiness and management, training, and document control
• Engage with cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution
• Author and implement Quality procedures, and training
• Identify compliance gaps and improvement opportunities to inform the corporate Quality Plan and/or Inspection Readiness plans
• Support and perform internal and external CDMO quality audits
• Develop and maintain Quality Technical Agreements

REQUIREMENTS
Education

• Bachelor’s degree in Life Sciences, Engineering, or a related field

Experience

• Minimum of 10+ years of pharmaceutical quality assurance experience in a GMP manufacturing environment
• Extensive knowledge of Quality Assurance principles, practices, and standards (e.g., US FDA GMP, EMA, and ICH Guidelines, etc.)
• GxP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH
• Demonstrated ability to function as both a functional leader and an individual contributor capable of defining and driving work independently
• Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines
• Flexibility to work non-traditional work hours when needed, given international operations across time zones
• Able to successfully manage workload and timelines
• Ability to travel to and work from CDMO sites, and or the Structure San Francisco office, and internationally as needed [up to 20%]
• Technical expertise in DS/DP/FG manufacturing processes and skilled in quality management of CDMOs and testing laboratories

The target salary range for this full-time role is $255,000 - $300,000 + 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.