Director, Quality Systems Jobs

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 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 of patients; and we push the envelope. Our lead program has completed multiple Phase 1 and Phase 2 clinical trials; we plan to initiate multiple clinical trials across several indications in 2023 and 2024.More information about Tourmaline can be found at www.tourmalinebio.com.

General Responsibilities:

Tourmaline is looking for a Director, Quality Systems to join us in this exciting opportunity to develop medicines in interesting and challenging therapeutic areas, and to serve patients who have life-altering immune diseases. In this leadership role at Tourmaline, you will work with seasoned professionals to build a world-class 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.The Director, Quality Systems will lead the selection and deployment of an electronic quality management system and oversee its day-to-day execution.This position reports to the Senior Vice President, Head of Quality and will have responsibility for future development and growth of the Quality Systems function.This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior levels of the organization, while making a strategic and tactical impact on the thing that matters most – driving our science and organization to deliver results for patients.

Responsibilities:

• Collaborate with and influence key personnel to align and facilitate harmonization of strategy, plans, procedures and processes related to the quality management system in a fit-for-purpose and phase-appropriate manner
• Develop, coach and train personnel to ensure that adequate quality oversight and understanding is built in to day-to-day operations
• Lead and grow the Quality Systems function to support GxP regulated activities for an expanding portfolio of global clinical stage programs
• Serve as the Quality representative on clinical project teams, as assigned
• Develop, implement and maintain key quality systems including but not limited to document and records management, training, deviation / CAPA management, supplier qualification and audits of internal operations and external parties
• Lead and manage cross-functional teams to drive the continuous improvement of quality processes and procedures, identify issues or gaps, and resolve them in a constructive manner
• Author, review and approve plans, policies, procedures and other documents
• Collaborate cross-functionally with all relevant functional areas to support corporate objectives
• Establish quality metrics to identify and manage risks and provide periodic reports to management on the performance of the quality management system
• Manage the selection, configuration, validation, deployment, operation and maintenance of the electronic quality management system and related infrastructure

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:

• Experience with deployment, use and maintenance of electronic quality management systems, preferably in a Software as a Service (SaaS) model.Experience migrating from a paper to an electronic-based quality system is desirable
• Excellent interpersonal skills, strategic thinking, high emotional intelligence, and the ability to develop important relationships with key stakeholders across disciplines
• Excellent analytical, negotiation and authoring skills, with strong oral and written communication skills
• Ability to exercise good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required
• Breadth of knowledge across various functional disciplines including Quality Systems, Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)
• Periodic travel to Tourmaline offices in New York is required
• Well-versed on regulatory compliance and industry practices for computer systems and electronic records / signatures (e.g., 21 CFR Part 11, EU Annex 11)
• 10+ years of relevant Quality experience including implementing and managing GxP quality systems in the pharmaceutical/biotech industry
• Familiar with ICH Q9 and ability to apply quality risk management principles
• Experience working in a virtual work environment at a small or mid-sized company is strongly preferred

Base Salary Range: $190,000 - $240,000, 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 applicable legally protected characteristics.