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About the Role

The Senior Director of GMP Quality Assurance will lead and execute the global GMP QA strategy, transitioning the company from clinical development to commercial readiness. This role involves designing scalable quality systems, overseeing preclinical GLP and clinical GMP operations, and ensuring compliance with global regulatory standards while partnering with cross-functional teams and external manufacturing partners.

Responsibilities

Serve as the functional leader for GLP/GMP Quality Assurance and a key member of the Quality Leadership Team.
Lead, develop, and manage the GLP/GMP Quality Assurance and QC Compliance teams.
Build and scale a high-performing quality organization to support growth from R&D through commercialization.
Develop and execute the GLP/GMP Quality strategy aligned with corporate objectives and regulatory expectations.
Establish a quality vision promoting compliance, inspection readiness, and operational excellence.
Provide leadership for Quality Management System processes including deviations, CAPAs, change controls, and risk management.
Ensure compliance with global regulations including FDA, EMA, ICH, OECD, and NMPA.
Provide strategic quality oversight of GLP-regulated nonclinical activities and GMP manufacturing/testing operations.
Oversee QC Compliance activities including laboratory investigations, data integrity, and analytical method lifecycle.
Lead organizational preparedness for internal and regulatory audits and inspections.
Provide strategic oversight of external partners including CROs, CMOs, and CDMOs.
Establish effective quality agreements, governance structures, and performance metrics for outsourced activities.
Exercise risk-based decision-making to resolve quality and compliance issues.
Partner with executive leadership to provide compliance guidance and risk-based recommendations.
Lead Quality Management Review meetings to drive continuous improvement and operational efficiency.

Requirements

15+ years of experience in GLP/GMP quality management in pharmaceutical or laboratory settings.
Proven leadership and management skills with a track record of building high-performing teams.
In-depth knowledge of GLP/GMP regulations, guidelines, and industry best practices.
Strong analytical and problem-solving abilities.
Excellent communication and interpersonal skills.
Strong organizational skills and attention to detail.
Ability to travel 10-20%.

Skills

GLP/GMP Quality Management
Quality Management Systems (QMS)
Regulatory Compliance (FDA, EMA, ICH, OECD, NMPA)
Strategic Leadership
Risk Management
QC Compliance
Audit and Inspection Readiness
Vendor/Partner Oversight
Data Integrity

Location

California
Shanghai

Work Type

Full-time

Experience Level

15+ years

Education Level

Bachelor's degree in a relevant scientific field
Master's degree or Ph.D. preferred
Certification in Quality Management is a plus

Salary/Compensations

$240,000 - $300,000 base pay

Benefits

Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical, dental, and vision insurance
401k match
Unlimited PTO
Paid holidays including winter shutdown

About the Company

Structure Therapeutics develops life-changing medicines using advanced structure-based and computational drug discovery technology.
The company focuses on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Led by international drug innovators and backed by top-tier global life sciences investors.
Publicly traded company (IPO February 2023) with offices in the US and China.

Equal Opportunity

Structure Therapeutics Inc. is an Equal-Opportunity Employer.