VP, Global Quality Assurance

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 Vice President of Global Quality Assurance (VP-QA) will be responsible for developing, implementing, and overseeing a comprehensive Quality Assurance (QA) strategy to ensure the highest standards of compliance across all global clinical, regulatory, and manufacturing operations. This role will serve as the primary Quality leader, ensuring that products, processes, and systems meet regulatory requirements, corporate objectives, and industry best practices.

The dynamic leader of Vice President of Global Quality Assurance will be responsible for all aspects of the Quality Assurance (QA) function at the Company, GxP compliance, and Quality Control (QC) of the Company’s products and activities. This role will oversee establishing a robust Quality Management System with quality plans and policies and proactively report regularly on compliance activities and findings. This role will also continue to design, implement and maintain QA, QC and compliance programs and infrastructure including a Quality System, training program, and oversee all GXP internal and external audits.

Reporting to the Senior Vice President of Global Regulatory Affairs and Quality Assurance, this position will serve as an in-house champion on GxP compliance as well as establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).

ESSENTIAL DUTIES AND RESPONSIBILITIES

Strategic Leadership:

• Develop and execute a global quality strategy aligned with corporate goals and regulatory
  requirements
• Drive a culture of quality excellence, compliance, and continuous improvement across the
  organization
• Act as a key member of the clinical leadership team, providing strategic insights on quality-related matters impacting clinical development, regulatory submissions, and commercialization

Compliance and Oversight:

• Ensure compliance with global regulatory standards, including FDA, EMA, and ICH guidelines
• Oversee the design, implementation, and maintenance of Quality Management Systems (QMS)to support clinical development and manufacturing activities
• Lead preparation for, and responses to, regulatory inspections, audits, and interactions

Operational Excellence:

• Establish and monitor quality metrics to identify trends, assess risks, and implement proactive
  solutions
• Lead the QA oversight of clinical trial activities, including Good Clinical Practice (GCP) compliance audits of sites, vendors, and internal systems
• Oversee Good Manufacturing Practice (GMP) activities for drug manufacturing, ensuring product quality and supply chain integrity

Team Leadership and Development:

• Build, manage, and mentor a high-performing global QA team
• Promote collaboration across Clinical, Regulatory, and Operations functions to achieve quality goals efficiently
• Ensure appropriate resources and training are in place to maintain compliance and support corporate growth

REQUIREMENTS

Education

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred)

Experience

• Minimum of 15 years of experience in Quality Assurance, with at least 5 years in a senior leadership role in the  pharmaceutical, biotech, or medical device industry
• Proven track record in global QA strategy development and implementation
• Comprehensive knowledge of GCP, GMP, GLP, and global regulatory requirements
• Leadership Skills
  • Strong ability to influence and lead cross-functional teams
  • Highly diplomatic
  • Flexible thinking and pragmatism
  • Experience developing and mentoring high-performing teams in a global environment
• Technical Skills
  • Expertise in regulatory inspections and audits
  • Strong analytical and problem-solving skills, with a proactive and results-oriented
    mindset
• Expert knowledge of GMP, ICH/GCP, and GLP FDA regulatory requirements; previous experience in APAC preferred
• Familiarity with discovery data integrity policies and quality assurance a plus
• Have strong technical skills, both functional and non-functional, manual and automation, ideally in a continuous delivery environment
• Demonstrated success in making informed decisions for the department
• The ability to prioritize and handle multiple activities daily yet flexibility and responsiveness to frequently shifting priorities
• Demonstrated ability to positively integrate into a team environment (US, APAC)
• Strong sense of ethics and honesty
• Collaborative in partnerships with Project Teams and individual team members
• Be an advocate of QA, Continuous Improvement, and industry-recognized Best Practices
• Excellent knowledge of Risk Management, Risk Identification, and Risk-based Testing
• Excellent communication, influencing, and negotiation skills to get management buy-in on ideas and concepts
• Ability to communicate with all levels of management and peers within the organization
• Ability to build, implement, and direct quality assurance principles and maintain the quality of delivery

Travel – 15%

The target salary range for this full-time role is $291,000 - $350,000 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.