- 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.
- Has a bias for action and display a sense of urgency. Must possess strong skills in leadership, communication, project management, and budget management.
- Demonstrated ability to collaborate, communicate and ensure quality oversight through external parties.
- A working knowledge of databases, including Electronic Document Management Systems (EDMS), is desirable.
- In‐depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices
- SQA RQAP certification is a plus
- Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance.
- Additional certifications as an auditor as well as training regulatory frameworks highly desirable.
- Expertise in data integrity and CFR Part 11 required.
- BS/MS or equivalent in a relevant scientific discipline. Graduate level in a science or engineering related discipline is preferred.
- 10+ years' experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for clinical stage pharmaceutical companies with at least 5 years' experience in an out-sourced environment. Thorough experience in quality function, overseeing clinical quality within European guidelines and regulatory standards.
- 5+ years' experience with Pharmaceutical Quality Assurance in the US. Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable.
- Ability to travel 10-30% domestically and internationally
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Director, Clinical Quality - South San Francisco, United States - Structure Therapeutics Inc
Description
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.
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 Director, 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.
Essential Duties and responsibilities
REQUIREMENTS
Education
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.
