Associate Director, QMS & CSA

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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