Manager II, Clinical Quality Assurance
Tarsus Pharmaceuticals, Inc.
6 months ago
Remote friendly (Orange County, CA)
United States
Clinical Research and Development
Manager II, Clinical Quality Assurance
Reporting to the Director of Clinical Quality Assurance, responsible for clinical quality support and management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) supplier qualification program.
Key responsibilities:
- Provide day-to-day clinical quality support and training to ensure adherence with applicable regulatory requirements, company policies, and procedures.
- Coordinate GCP/GLP/GVP internal and supplier audit activity, including management and maintenance of the qualification program’s audit schedule within the Quality Management System (QMS).
- Perform supplier audits and prepare author reports, as needed.
- Compile audit responses and review implementation evidence.
- Support implementation of quality systems and processes within the Clinical Quality area.
- Review and approve QMS records (deviations, CAPAs, change controls, etc.) for completeness and adherence to SOPs and applicable regulations.
- Assist in remediation and corrective action plans and monitor quality issues to resolution.
- Assist with review of Clinical Quality Management Plans (CQMPs) for clinical trials and/or vendor performance, as needed.
- Manage clinical training curricula.
- Assist in creation of tracking tools to report quality metrics, as necessary.
- Support review of and/or perform Risk Assessments, as needed.
- Assist with oversight and conduct periodic reviews of clinical trial systems (e.g., CTMS, TMF).
- Work closely with Quality Management to ensure compliance with applicable guidelines, regulations, and SOPs.
- May serve as a resource for Clinical Development/Operations and Quality.
Factors for success (qualifications):
- 8 years of clinical experience
- 5 years of experience within the pharmaceuticals industry
- Bachelor’s Degree in Scientific Field (preferred)
- In-depth knowledge of clinical trial-related FDA regulations and ICH Guidelines; experience with international GCP/GLP/GVP regulations and guidelines (desired)
- Extensive knowledge in Risk-Based Management (RBM), global clinical regulations, and clinical development
- Experience with investigations using root cause analysis, CAPA, and CAPA effectiveness checks
- In-depth knowledge of auditing planning, principles, techniques, and communication to convey findings and report deficiencies
- Ability to work with internal and external personnel to increase compliance and improve operations and reduce errors
- Ability to adapt to shifting priorities in a fast-paced environment
- Strong computer and organizational skills; strong attention to detail
- Decision-making, collaboration/team building, and outcome-driven mindset
Additional details:
- Hybrid work environment (Irvine office); some travel up to 20%.
- Base pay range: $120,000–$168,000 plus bonus, stock equity, and comprehensive benefits (health, dental, and vision insurance) and generous paid time off.
Benefits details link (as provided): https://eb.alliant.com/26tarsusbenefitssnapshot.
Reporting to the Director of Clinical Quality Assurance, responsible for clinical quality support and management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) supplier qualification program.
Key responsibilities:
- Provide day-to-day clinical quality support and training to ensure adherence with applicable regulatory requirements, company policies, and procedures.
- Coordinate GCP/GLP/GVP internal and supplier audit activity, including management and maintenance of the qualification program’s audit schedule within the Quality Management System (QMS).
- Perform supplier audits and prepare author reports, as needed.
- Compile audit responses and review implementation evidence.
- Support implementation of quality systems and processes within the Clinical Quality area.
- Review and approve QMS records (deviations, CAPAs, change controls, etc.) for completeness and adherence to SOPs and applicable regulations.
- Assist in remediation and corrective action plans and monitor quality issues to resolution.
- Assist with review of Clinical Quality Management Plans (CQMPs) for clinical trials and/or vendor performance, as needed.
- Manage clinical training curricula.
- Assist in creation of tracking tools to report quality metrics, as necessary.
- Support review of and/or perform Risk Assessments, as needed.
- Assist with oversight and conduct periodic reviews of clinical trial systems (e.g., CTMS, TMF).
- Work closely with Quality Management to ensure compliance with applicable guidelines, regulations, and SOPs.
- May serve as a resource for Clinical Development/Operations and Quality.
Factors for success (qualifications):
- 8 years of clinical experience
- 5 years of experience within the pharmaceuticals industry
- Bachelor’s Degree in Scientific Field (preferred)
- In-depth knowledge of clinical trial-related FDA regulations and ICH Guidelines; experience with international GCP/GLP/GVP regulations and guidelines (desired)
- Extensive knowledge in Risk-Based Management (RBM), global clinical regulations, and clinical development
- Experience with investigations using root cause analysis, CAPA, and CAPA effectiveness checks
- In-depth knowledge of auditing planning, principles, techniques, and communication to convey findings and report deficiencies
- Ability to work with internal and external personnel to increase compliance and improve operations and reduce errors
- Ability to adapt to shifting priorities in a fast-paced environment
- Strong computer and organizational skills; strong attention to detail
- Decision-making, collaboration/team building, and outcome-driven mindset
Additional details:
- Hybrid work environment (Irvine office); some travel up to 20%.
- Base pay range: $120,000–$168,000 plus bonus, stock equity, and comprehensive benefits (health, dental, and vision insurance) and generous paid time off.
Benefits details link (as provided): https://eb.alliant.com/26tarsusbenefitssnapshot.