Job Title: Director, Quality Compliance
Reports To: SVP, Head of Quality
Functional Area: Quality
Position Location: Remote (possible hybrid)
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.
The Director, Quality Compliance, with support from Quality leadership, has overall responsibility for GxP-regulated programs including supplier qualification, internal/external auditing, and the conduct of quality management review (QMR). This role routinely collaborates and interacts with internal stakeholders and external parties to drive Tourmaline’s GxP compliance objectives.
- Lead the development, implementation, maintenance, and continuous improvement of the supplier qualification and internal/external audit programs to ensure appropriate supplier qualification and oversight and robust GxP compliance risk identification and mitigation.
- Collaborate across functional areas to identify, plan, and facilitate the timely completion of supplier qualification deliverables such as quality agreements, supplier corrective actions, and supplier scorecards.
- Oversee all aspects of the internal/external audit program including audit preparation, execution, reporting, response, implementation of corrective/preventative actions, and any required follow-up actions.
- With Quality leadership support, secure and assign resources to perform audit related activities, including from colleagues and consultants as needed. Ensure roles and responsibilities are well defined, while maintaining overall oversight of the audit program.
- Conduct internal/external audits as assigned.
- Develop, maintain, and issue internal/external audit schedules.
- Ensure that auditors meet Tourmaline’s qualification requirements and receive any required training.
- Lead or participate in meetings to discuss and facilitate closure of unresolved issues with auditees and internal stakeholders.
- Develop, maintain, and report audit metrics. Communicate adverse trends and critical quality issues to Quality leadership.
- Lead the development, implementation, maintenance, and continuous improvement of the QMR program to regularly provide relevant compliance insights and identify continuous improvement opportunities.
- Collaborate across functional areas to identify relevant QMR content and provide guidance on the preparation of QMR meeting materials.
- Coordinate QMR meetings and issue meeting agendas, materials, and agendas.
- Assist Quality leadership with establishing functional area objectives and goals.
- Support corporate and third-party inspection readiness activities.
- Provide consultation on, and interpretation of regulations, guidelines, compliance status and policies and procedures to project teams, as assigned within Tourmaline.
- Bachelor’s degree required
- Advanced degree or relevant certifications are a plus
Experience and Attributes:
- 10+ years of relevant Quality experience in the biotech/pharmaceutical industry
- Experience working in a virtual work environment at a small or mid-sized company is strongly preferred
- 5+ years prior auditing experience including all aspects from audit planning through closure
- 3+ years of experience managing employees or consultants
- Working knowledge of applicable GxP regulations and guidance including Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Familiarity with combination product/medical device regulations is desirable
- Thorough knowledge of drug substance and drug product manufacturing operations and key performance indicators/metrics
- 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
- Ability to travel periodically to perform audits (up to 10%)
- 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-$229,000, based on candidate 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 email@example.com. Be sure to include the title of the position of interest in your email.
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.