Job Title: Senior Director, CMC Quality Assurance
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 late-stage clinical biotechnology company with a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts on 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 asset is pacibekitug (also known as TOUR006), a long-acting, fully-human, anti-IL-6 monoclonal antibody. Pacibekitug has previously completed multiple Phase 1 and Phase 2 clinical trials. Tourmaline is developing pacibekitug in thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD) as its first two indications, with additional diseases under consideration. More information about Tourmaline and pacibekitug can be found at www.tourmalinebio.com.
General Responsibilities:
The Senior Director, CMC Quality Assurance (QA) is responsible for building and overseeing a high-performing team that provides overall QA support of CMC activities to successfully move product through clinical development and planning for commercial inspections and launch. This role provides strategic direction and hands-on tactical support for the development, implementation, and maintenance of a phase appropriate quality management system (QMS) for CMC activities that ensures compliance with global regulatory requirements, guidelines, and industry best practices. This position works collaboratively across the company to support risk-based quality objectives, fostering a quality culture that drives continuous quality improvement in a growing and dynamic organization.
Responsibilities:
- Lead, grow, manage, and mentor the CMC Quality Assurance team to provide quality oversight of regulated activities.
- Collaborate with the Quality team and cross-functionally to define and execute strategy, goals, objectives, plans, and procedures that enable a fit-for-purpose QMS for CMC activities and to foster a quality culture throughout Tourmaline.
- Partner with program teams to ensure successful planning, execution, and delivery of projects, bringing the quality and compliance perspective to all activities.
- Develop, manage, and improve GMP quality systems, including but not limited to change management, product complaint management, quality management review, and issue management.
- Collaborate with the Quality team to develop and implement audit programs to ensure that internal operations and vendors are compliant with current regulations and best practices.
- Generate, review, and/or approve internal and external documents and records pertaining to GMP activities (e.g., procedures, training materials, batch records, analytical methods, specifications, investigations, protocols, reports).
- Oversee and perform disposition activities for Tourmaline materials and products.
- Work with internal and external stakeholders to establish and maintain quality agreements and qualified person agreements with third parties.
- Ensure high-quality content, accuracy, and integrity of regulatory submission documents.
- Ensure that potential quality issues are resolved, mitigated, and that appropriate corrective/preventative actions are identified and implemented.
- Develop and execute CMC-related regulatory authority inspection readiness activities.
- Support executive management with CMC-related regulatory authority inspections and due diligence activities.
Education and Licensure:
- Bachelor’s degree in a relevant field is required.
Experience and Attributes:
- Minimum 15 years of biotechnology/pharmaceutical industry experience including 8 years in a relevant Quality field is required
- Minimum 3 years of management/supervisory experience is required
- Extensive knowledge of cGMP and ICH requirements for product development and manufacturing, including technical knowledge of analytical and standard compendial physical, chemical, and microbiological methods is required
- Experience with contract management organization (CMO) oversight is required
- Experience with small molecule and/or biologics products, additional experience with medical device combination products (e.g., prefilled syringe, auto-injector) is strongly preferred
- Experience in late-phase clinical development environment and additional commercial experience is strongly preferred
- Ability to independently assess R&D and manufacturing activities for compliance with regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective and preventative actions, and participate or lead team-based solutions
- Ability to lead cross-functional teams to prepare for regulatory authority inspections and to identify, mitigate, and address compliance risks and issues
- Excellent analytical, organizational, interpersonal, oral and written communication skills, and attention to detail
- High level of integrity, ethics, and discretion
- Strong negotiation and collaboration skills, strategic thinking, high emotional intelligence, and the ability to develop effective relationships with key stakeholders across disciplines within the organization and with third parties
- Strong leader and team player who demonstrates initiative, willingness to roll-up their sleeves, and problem solve
- Demonstrated ability to prioritize multiple tasks and work in a fast-paced, dynamic environment with tight deadlines
- Proficiency with MS Office, MS Project, PowerPoint, and eCTD format
- Periodic travel to Tourmaline offices in New York and physical attendance at other project and team meetings may be required
Base Salary Range:
$219,000 – $261,000 based on candidate 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.
