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Quality Systems Senior Manager
Longboard PharmaceuticalsLa Jolla, United Statesfull_timeVerifiedPosted 27 Jun 2024
💰 $140,000/yr($125,000/yr – $140,000/yr)
About the role
Job Title: Quality Systems Sr. Manager
Reporting To: VP, Head of QA
Department: Quality Assurance
People Manager: No
FLSA Status: Exempt
Location: La Jolla, CA
Schedule: Hybrid, 2-3 days a week in office
Position Summary
This position is an integral part of the Quality Assurance & Compliance function at Longboard Pharmaceuticals. The Quality Systems position will ensure appropriate and constant support and vigilance in the areas of GLPs, GCPs, and cGMP commensurate with domestic and international regulations and guidances, and internal Standard Operating Procedures.
This position manages the oversight of Quality Management systems such as deviations, CAPA, Quality Incidents, and document generation and change control. This role will support oversight of the quality of regulatory documentation in Veeva Quality Docs, Veeva TMF and Veeva QMS. This role will provide QMS input and drive quality principles, quality metrics, and GxP training compliance. The successful candidate will independently develop quality and compliance metrics to show the state of compliance and inspection readiness. This role is accountable for the routine execution of Quality Assurance Compliance duties related to Longboard’s drug development programs, as well as oversight of the continued development, implementation, maintenance, and performance of the GxP Quality Assurance systems both within Longboard and external vendors supporting Longboard activities.
Responsibilities include but may not be limited to:
• Ensuring that the Longboard Quality Management System is compliant with applicable Regulatory and Industry Standards, and internal procedures
• Participating in Quality System process activity across multiple functions including quality system projects and initiatives
• Periodic audits/review of Trial Master Files (TMFs) for ongoing trials to ensure accuracy and completeness
• Periodic audits of third-party contractors working on behalf of Longboard
• Conducting “Lookbacks” or gap analyses of existing Clinical Files supporting completed Longboard Clinical studies to determine accuracy and completeness
• Maintaining Quality Metrics to showcase areas of improvement and state of compliance
• Training cross-functional teams on pertinent use of QMS (Quality Incident, CAPA, Change Control, GxP Training, etc.)
• Formulating and executing strategies and roadmaps within the scope of Longboard’s Quality plans
• Collaborating closely with the Clinical Operations Team, Regulatory Affairs & CMC functions to provide expert quality assurance information, address identified issues, and drive continuous improvement
• Maintaining up-to-date knowledge of relevant regulatory requirements and ensuring congruency for the rest of the team
• Supporting the development and implementation of Standards, Processes, and Procedures.
• Preparing technical material, reports, and forms using a wide variety of text editing software and managing features (formatting, editing, deleting, updating, etc.).
• Review of QA department processes and make recommendations on these processes.
Minimum Requirements
Reporting To: VP, Head of QA
Department: Quality Assurance
People Manager: No
FLSA Status: Exempt
Location: La Jolla, CA
Schedule: Hybrid, 2-3 days a week in office
Position Summary
This position is an integral part of the Quality Assurance & Compliance function at Longboard Pharmaceuticals. The Quality Systems position will ensure appropriate and constant support and vigilance in the areas of GLPs, GCPs, and cGMP commensurate with domestic and international regulations and guidances, and internal Standard Operating Procedures.
This position manages the oversight of Quality Management systems such as deviations, CAPA, Quality Incidents, and document generation and change control. This role will support oversight of the quality of regulatory documentation in Veeva Quality Docs, Veeva TMF and Veeva QMS. This role will provide QMS input and drive quality principles, quality metrics, and GxP training compliance. The successful candidate will independently develop quality and compliance metrics to show the state of compliance and inspection readiness. This role is accountable for the routine execution of Quality Assurance Compliance duties related to Longboard’s drug development programs, as well as oversight of the continued development, implementation, maintenance, and performance of the GxP Quality Assurance systems both within Longboard and external vendors supporting Longboard activities.
Responsibilities include but may not be limited to:
• Ensuring that the Longboard Quality Management System is compliant with applicable Regulatory and Industry Standards, and internal procedures
• Participating in Quality System process activity across multiple functions including quality system projects and initiatives
• Periodic audits/review of Trial Master Files (TMFs) for ongoing trials to ensure accuracy and completeness
• Periodic audits of third-party contractors working on behalf of Longboard
• Conducting “Lookbacks” or gap analyses of existing Clinical Files supporting completed Longboard Clinical studies to determine accuracy and completeness
• Maintaining Quality Metrics to showcase areas of improvement and state of compliance
• Training cross-functional teams on pertinent use of QMS (Quality Incident, CAPA, Change Control, GxP Training, etc.)
• Formulating and executing strategies and roadmaps within the scope of Longboard’s Quality plans
• Collaborating closely with the Clinical Operations Team, Regulatory Affairs & CMC functions to provide expert quality assurance information, address identified issues, and drive continuous improvement
• Maintaining up-to-date knowledge of relevant regulatory requirements and ensuring congruency for the rest of the team
• Supporting the development and implementation of Standards, Processes, and Procedures.
• Preparing technical material, reports, and forms using a wide variety of text editing software and managing features (formatting, editing, deleting, updating, etc.).
• Review of QA department processes and make recommendations on these processes.
Minimum Requirements
- More than 7-10 years of Biotech/Pharma experience
- Must possess thorough knowledge of GxP regulatory requirements and guidelines
- Understanding of FDA and international regulations, and quality requirements
- Proficient in, MS Office, Veeva, SAP, SharePoint, Tableau
- Soft skills specific to team building and conflict resolution
- Excellent presentation, writing, verbal, and interpersonal skills
- Effectively influences actions and opinions of others. Ability to independently perform effectively and efficiently in a fast-paced environment.
- Ability to assess procedures, policies, work instructions, and site forms to improve processes and Quality Systems
- Ability t
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