Quality Systems Senior Manager

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

• 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 to travel up to 15% of the time
• Ability to work constructively across all functions of the organization as well as with external customers
  
  

About Longboard

At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.

Pay Transparency

The expected salary for candidates who work in La, Jolla, CA is $125,000.00 - $140,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.

Benefits

At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.

Our Benefits Currently Include

• Hybrid work schedule out of our La Jolla office, 2-3 days a week
• Competitive compensation package including bonus opportunities and stock options
• Medical, Dental & Vision Plans
• 401(k) Plan, including company match with immediate vesting
• Flexible Time Off, including one week off in the summer and one week off around December holidays
• 11 paid company holidays per year
• An opportunity to do truly meaningful work to make a lasting impact
• Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
• Flexible spending account for medical care
• Life insurance, short and long term disability plans