Associate Director, QMS (Quality Management Systems) & CSA (Computer Software Assurance
Structure Therapeutics is seeking an Associate Director, GxP Operations to lead the development and management of the company's IT Computer System Validation (CSV), Computer Software Assurance (CSA), and IT GxP compliance programs. This role is pivotal in ensuring that all GxP-regulated computerized systems across clinical, quality, regulatory, pharmacovigilance, manufacturing, and supply chain operations are implemented, validated, and maintained in compliance with global regulatory requirements. The position reports to the Senior Director, IT Business Partner - R&D and will be an individual contributor role.
The Associate Director will build and lead the enterprise IT CSV and CSA programs from the ground up, establishing risk-based validation methodologies aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and ICH guidelines. Responsibilities include developing and maintaining IT GxP policies, standard operating procedures, and work instructions, overseeing the validation and ongoing compliance of enterprise GxP applications, and leading the transition from traditional CSV to a modern, risk-based CSA approach. Additionally, the role involves serving as the IT subject matter expert for regulatory agency inspections, ensuring inspection readiness across IT systems, data integrity controls, and validation documentation.
Candidates should possess a Bachelor's degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field, with an advanced degree preferred. A minimum of 10 years of progressive experience in IT GxP compliance, computer system validation, software quality assurance, or IT governance within the pharmaceutical, biotechnology, or medical device industries is required, including at least 5 years in a senior or leadership capacity. Experience with Veeva Vault, Veeva RIM, or similar enterprise GxP platforms is essential. The ideal candidate will have a demonstrated track record of building or scaling a CSV/CSA program within a regulated life sciences environment, ideally at a clinical-stage or pre-commercial biotech company.
Structure Therapeutics offers a competitive compensation package, with the anticipated base pay range for this role between $200,000 and $253,000. The exact base pay offered will depend on various factors, including the candidate’s geography, qualifications, skills, and experience. In addition to base pay, the successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. The company also provides various benefits offerings, including medical, dental, and vision insurance, 401(k) match, unlimited PTO, and a number of paid holidays, including winter shutdown.
Structure Therapeutics is a clinical-stage company focused on developing 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. With offices in California and Shanghai, Structure Therapeutics is at the center of life science innovation in both the US and China, capitalizing on the strengths of each geographic location.