Job Title: Associate Director, CMC Quality Assurance
Reports To: Director, CMC Quality Assurance
Functional Area: Quality
Position Location: Remote
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, CMC Quality Assurance reports directly to the Director, CMC Quality Assurance and is responsible for the QA oversight of day-to-day CMC operations for Tourmaline, including those performed at the Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs) that manufacture and/or test Tourmaline’s products. In addition, this role provides strategic leadership in support of continuous improvement, risk mitigation, and data integrity pertaining to product manufacturing and quality management system to ensure a culture of quality and compliance.
Responsibilities:
- Provide strategic leadership to develop, establish, and maintain the QA programs, policies, and procedures to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
- Perform record review and product disposition activities for Tourmaline materials and products.
- Coordinate investigations with vendors and interdepartmental teams to resolve potential quality issues, mitigate risks, and ensure that appropriate corrective/preventative actions are identified and implemented.
- Oversee the generation, review and/or approval of internal and external documents used in GMP activities.
- Support device design control activities and documentation reviews, including preparation / maintenance of Device History File.
- Support the management and continuous improvement of quality systems, including but not limited to supplier qualification, change management, product complaint management, quality management review, and deviation/CAPA management.
- Ensure that Tourmaline and its vendors are inspection-ready for health authority inspections by regulatory agencies.
- Drive efficiencies and support the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing (filling, labeling, packaging, and distribution).
- Review and/or approve various documents such as, but not limited to, manufacturing, testing and labeling / packaging batch records, risk assessments, specifications, and protocols and reports for stability and qualification / validation activities.
- Perform data integrity and compliance assessments including review against source documents for regulatory submissions.
- Author templates, work instructions, standard operating procedures and other documentation to support GMP activities.
Education:
- BS/BA degree in related discipline and a minimum of ten years of related experience; or, MS/MA degree in related discipline and a minimum of seven years or related experience.
Experience and Attributes:
- Experience in drug combination product development and manufacturing is required, including experience in 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 4 (Combination Products)
- Minimum 3 years of experience in CMO oversight is required
- Working knowledge of clinical manufacturing and quality processes, including US and EU regulations and ICH guidelines affecting the pharmaceutical industry
- Excellent verbal and written communication skills
- Must be proficient in Word, Excel, and PowerPoint; familiarity with electronic quality management systems
- Willingness to work hard in a dynamic environment with changing priorities
- High level of integrity, ethics and discretion
- Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines
- A good team player with 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: $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 applicable legally protected characteristics.
