Job Title: Associate Director, Quality Systems
Reports To: Director, Quality Systems
Functional Area: Quality
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts with a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our Phase 2b clinical trial in Thyroid Eye Disease (TED) in 2023 and our Phase 2 clinical trial in cardiovascular disease in Q2 2024. We plan to initiate our Phase 3 clinical trial in TED later in 2024. More information about Tourmaline can be found at www.tourmalinebio.com.
General Responsibilities:
The Associate Director, Quality Systems reports directly to the Director, Quality Systems and is responsible for leading and/or supporting the design, implementation and/or operations of electronic Quality Management Systems (eQMS), including document management, training management, supplier management and other quality processes at Tourmaline. This role leads and/or supports GxP computer systems lifecycle management activities across GxP areas.
Responsibilities:
Computer Systems Lifecycle Management:
- Lead/support computer system validation (CSV) activities for new and existing electronic Quality Management Systems (eQMS) that support GxP related activities , which may include risk assessments, planning, design, testing, implementation, data migration, training, etc.
- Provide documentation support for CSV deliverables such as authoring, review and/or approval of SOPs, work instructions, risk assessments, validation plan/summary, user/functional requirement specifications, test plan/summary, etc.
- Serve as system owner responsible for system administration, system security, system change control, user support, troubleshooting, and maintenance for applicable eQMS.
- Monitor system performance, identify gaps & improvement opportunities, and implement system enhancements in collaboration with user community, IT and computer system supplier partners.
Document Management
- Serve as document control and provide necessary document management support to GxP functions to ensure compliance with documentation and data integrity requirements; activities may include authoring, review and/or approval, periodic review, etc.
- Continuously monitor process compliance with business and system requirements by identifying key performance metrics, implementing reporting/dashboard needs, and identifying improvement opportunities.
- Assess current state of GxP documentation and support document migration to the new electronic system.
Training Management
- Serve as training administrator for GxP functions to ensure compliance with relevant regulatory requirements; activities include but are not limited to creation and/or maintenance of training plans, training records, job descriptions, CVs and other training-related documentation.
- Serve as subject matter expert and provide training guidance and support to non-GxP functions.
Other QMS Processes
- Provide operational support for event management, CAPA management, change control, and audits to GxP personnel.
- Provide cross-functional support to projects and continuous improvement activities as needed.
Education:
- Bachelor’s degree in life sciences, engineering, or related field.
- Equivalent combination of education and applicable job experience may be considered.
Experience and Attributes:
- Minimum of 8 years related biopharma experience.
- Minimum 3 years direct experience in computer system validation in a GxP environment.
- Knowledge of US and EU regulations, ICH guidelines and industry best practices related to Quality Management Systems.
- Working knowledge of electronic QMS with preferred experience in Veeva Systems.
- Proven strong writing, communication, problem-solving and project management skills.
- Advanced knowledge of Microsoft Word and Excel.
- High level of integrity, ethics and discretion with ability to prioritize, multi-task and work independently.
- Collaborative team player and leader with ability to negotiate, influence and drive results toward a common goal.
- Occasional travel may be required to support special projects and attend Tourmaline All Hands meetings.
Base Salary Range:
$166,000 – $200,000 based on candidate’s professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
