What are the responsibilities and job description for the Sr. Director, Global QA Clinical Quality Assurance position at Structure Therapeutics?
Job Description
Job Description
Salary :
Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys 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 clinicalstage 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.
POSITION SUMMARY
The Sr. Director, Global QA Clinical Quality Assurance is responsible for development, governance, and management of GCP and ensuring other product development and PV activities comply with applicable national and international standards, regulations, and guidelines. The position will provide support and promote collaboration internally to ensure all systems, processes and their outcomes remain compliant. The position will also provide quality oversight of multiple programs in development, based on company goals. 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. #LIHybrid. The preference is local to the Bay Area.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Support the preparation and implementation of regulatory strategies, for new drug Lead Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP compliance
- Ensure involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, RA, PV etc. to influence effective processes and program oversight
- Lead in preparation and support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors / 3rd parties. Provide training and support for inspections at sites, CROs and service providers
- Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial essential documents (e.g. protocols, ICF, etc.)
- Evaluate vendors for potential use; conduct and / or manage qualification inspections of GCP suppliers and service providers
- Create and execute clinical study audit plans, perform routine and for-cause audits of clinical investigator sites, and review of TMFs and CSRs
- Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance issues. Create, monitor, and improve a QMS with focus on development phases
- Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity
- Lead, investigate, and / or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews
- Participate in department cross-training and lead / support during regulatory inspections, serving as QA clinical expert and host inspections as needed. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
- Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs
- Other duties as assigned
REQUIREMENTS
Education
Experience
The target salary range for this full-time role is $255,000 - $306,000 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.
remote work
