Director, Quality Systems

Job Title: Director, Quality Systems

Reports To: Senior Vice President, Head of Quality

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 first clinical trial in Thyroid Eye Disease (TED) in Q3 2023 and plan to initiate additional clinical trials in 2024, one of which is expected to be in cardiovascular disease.  More information about Tourmaline can be found at www.tourmalinebio.com.

General Responsibilities:

The Director, Quality Systems is responsible for building and overseeing a high-performing Quality Systems function that enables and supports GxP-regulated activities.  Primary responsibilities include providing strategic direction and hands-on tactical support for the development, implementation, and maintenance of phase-appropriate quality systems that ensure compliance with global regulatory requirements, guidelines, and industry best practices.   

Responsibilities:

  • Lead, grow, and manage the Quality Systems function to support GxP-related activities and corporate objectives for an expanding portfolio of global clinical stage programs.
  • Develop, implement, and maintain quality systems, including but not limited to, document and records management, training, deviation management, CAPA management, change control, and validation.  Ensure the integration of appropriate quality risk management methodologies and tools and provide guidance on their utilization. 
  • Collaborate with the Quality team and cross-functionally to define and execute strategy, plans and procedures that enable a fit-for-purpose quality management system and to foster a quality culture throughout Tourmaline. 
  • Manage the configuration, validation, deployment, operation, maintenance, and administration of the electronic quality management system and related infrastructure. 
  • Proactively monitor and drive the continuous improvement of the quality management system, identify issues/gaps and other opportunities for improvement, and resolve them in a compliant and constructive manner, ensuring compliance with regulations and standards.
  • Author, review, and approve policies, procedures, work instructions, risk and impact assessments, computer system validation deliverables, and other documents and records. 
  • Establish, generate, and trend quality metrics to identify and manage risks and provide periodic reports to management and other stakeholders on the performance of the quality management system.
  • Participate in quality management review (QMR) meetings. 
  • Develop, coach, and train personnel to ensure that adequate quality oversight and understanding is built into day-to-day operations.
  • Assist Quality leadership with establishing functional area objectives and goals.
  • Support corporate and third-party audits and inspection readiness activities.

Education:

  • Bachelor’s degree required.
  • Advanced degree or relevant certifications are a plus.

Experience and Attributes:

  • 10+ years of Quality Systems experience in the pharmaceutical/biotech industry
  • Experience working in a virtual/remote work environment at a small or mid-sized company is strongly preferred
  • 3+ years of experience managing employees or consultants 
  • Experience with validation, testing, deployment, use, and maintenance of GxP-regulated computer systems in a Software as a Service (SaaS) model
  • Proficient in the set-up and use of electronic quality management systems.  Experience with Veeva Vault is highly desirable
  • Working knowledge of applicable regulations and guidance including Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
  • Well-versed on regulatory compliance and industry best practices for computer systems and electronic records / signatures (e.g., 21 CFR Part 11, EU Annex 11)
  • Familiar with ICH Q9 and the application of quality risk management principles and tools
  • Excellent analytical, problem-solving, organizational, interpersonal, oral and written communication skills, and attention to detail
  • Strong negotiation skills, strategic thinking, high emotional intelligence, and the ability to develop effective relationships with key stakeholders across disciplines
  • Demonstrated ability to prioritize multiple tasks and work in a fast-paced, dynamic environment with tight deadlines
  • A good team player with a solid record of collaboration within and across functional areas
  • Periodic travel to Tourmaline offices in New York and physical attendance at other project and team meetings may be required

Base Salary Range:

$192,000 Р$229,000, based on candidate’s professional experience level.

If you have a passion for our mission at Tourmaline, we would love for you to join our team. To apply for any of our open positions, email your resume to jobapplicants@tourmalinebio.com. Be sure to include the title of the position of interest in your email.

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.