Associate Director, Clinical Quality

Job Title: Associate Director, Clinical Quality

Reports To: Senior Director, Clinical 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 Associate Director, Clinical Quality oversees and coordinates the quality assurance program for assigned projects and promotes and assesses compliance with regulations, guidelines and Standard Operating Procedures (SOPs). This position works collaboratively across the company to optimize risk-based quality strategies, fostering a quality culture that drives continuous quality improvement in a growing and changing organization.  This role provides hands-on tactical support for the development, implementation, and maintenance of a phase appropriate clinical quality management system (QMS) that ensures compliance with regulatory requirements, guidelines, and industry best practices.

Responsibilities:

  • Support GCP/GVP regulated activities and corporate objectives for clinical stage programs.
  • Partner with Quality leadership and internal and external stakeholders to identify and assess risks to GCP/GVP activities and apply collaborative problem-solving strategies to mitigate them.
  • Provide quality guidance to cross-functional development teams including the review of critical documents (e.g., study protocols, study-specific plans and manuals, investigator’s brochure, periodic reports).
  • Participate and support the clinical inspection readiness program, including review and preparation of plans, storyboards, training materials and inspection logistics.
  • Support/participate in planning, scheduling, preparation, conduct, reporting, and close out for all audits assigned. This may include, but is not limited to, in process, clinical investigational sites, and vendor/supplier audits.   
  • Manage or assist in (internal and external) GCP Quality Events including, but not limited to investigations, CAPAs, Root Cause Analysis, and Effectiveness Checks.
  • Serve as the author/reviewer for QA SOPs and similar documents. Provide input on the development of SOPs and training programs for development teams.
  • Oversee the documentation and reporting quality/compliance issues relating to the product, process, or quality system.  Trend, collect and report quality metrics as required to Quality management. 
  • Perform initial triage of event criticality working with operational Quality or Program leads and other subject matter experts, as needed.
  • Utilize quality tools and techniques to support or perform and document full root cause investigations to evaluate and resolve quality issues and to enhance continuous improvement.
  • Escalate critical and major finding to Quality management and monitor key performance indicators.
  • Assist in tracking of event completion in expected timeframes, as needed, and monitor quality of investigation writing.
  • Contribute to the quality management review (QMR) process, provide feedback and guidance from a GCP/GVP quality perspective, and assist with risk mitigation planning and execution.
  • Support efforts to implement and use technologies (e.g., electronic QMS, electronic trial master file, safety database) to optimize quality and support business needs.
  • Assist in additional Quality Assurance initiatives as applicable.

Education:

  • Bachelor’s degree required.
  • Advanced degree or relevant certifications (e.g., Certified Quality Auditor (CQS) and Registered Quality Assurance Professional (RQAP)) are a plus.

Experience and Attributes:

  • Minimum 8 years of clinical Quality experience in the pharmaceutical/biotech industry
  • Strong understanding of global GCP regulations and guidance (e.g., ICH GCP E6; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive)
  • Understanding of global GVP regulations and guidance (e.g., European Union Directive 2010/84/EU and current modules)
  • Support and participate in regulatory authority inspections (e.g., FDA Bioresearch Monitoring Program) associated with a new marketing application.
  • Familiar with ICH Q9 and the application of quality risk management principles and tools.
  • Significant experience planning and conducting internal, investigational sites and vendor audits. 
  • Excellent analytical, organizational, interpersonal, oral and written communication skills, and attention to detail and ability to positively influence and guide others.
  • Strong negotiation and collaboration skills, strategic thinking, high emotional intelligence, and the ability to develop effective relationships with key stakeholders across disciplines.
  • Strong team player who demonstrates initiative and willingness to proactively contribute to solving problems.
  • Experience successfully leading event investigations, Root Cause Analysis and CAPA.
  • Experience in quality analytics and using data to make decisions and identify trends.
  • Demonstrated ability to prioritize multiple tasks and work in a fast-paced, dynamic environment with tight deadlines.
  • Familiar with validation, testing, deployment, use, and maintenance of GxP-regulated computer systems.
  • Periodic travel to Tourmaline offices in New York and physical attendance at other project and team meetings may be required.

Base Salary Range: $172,000 – $206,000, 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.