Senior Director, Quality Assurance

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation - debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases. Despite the availability of multiple approved medicines, there is an urgent need for new treatment options. We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles - and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important. Bring your full self to work and create space for others to do the same. Balance candor with empathy.

Own the Big Picture

Context is critical. Ground every decision and action in the entirety of what we are trying to achieve.

Go THRD

We hold ourselves to a higher standard. Work with urgency, purpose, and passion.

The Role

The Sr. Director, Quality Assurance is a new position at THRD and will play a critical role in ensuring that our products meet regulatory requirements and adhere to the highest quality standards, from early stage through commercialization; providing GXP expertise and guidance for all THRD products. This position offers the opportunity to build a Quality function and make a significant impact to all facets of Quality, from strategy to implementation.

Responsibilities

• Develop and implement a comprehensive quality management strategy to ensure compliance with regulatory requirements, including FDA and other relevant authorities; immediate focus is on general quality systems and clinical quality oversight.

• Establish and maintain quality policies, procedures, and documentation to support product development; create and/or oversee SOP development, ensuring best practice and compliance with evolving industry standards.

• Oversee quality vendors responsible for GXP audits, compliance, and GMP batch record review.

• Collaborate cross-functionally with Clinical Operations, Nonclinical Development, CMC, and other key stakeholders to ensure appropriate quality oversight throughout the product lifecycle.

• Lead the development of audit plans for clinical programs; manage execution of those plans in collaboration with key internal and external stakeholders.

• Work closely cross-functionally within Regulatory, IT, and with key stakeholders to create a roadmap for future electronic QMS implementation.

• Monitor key quality metrics to evaluate the effectiveness of the quality management system and make recommendations to leadership, as needed, on risk mitigation strategies or corrective actions.

• Oversee quality training program and work with functional areas and HR to ensure appropriate training and onboarding for new employees

• Serve as the primary contact for regulatory agency inspections.

Minimum Qualifications

• Bachelor's degree, with clinical, chemistry and/or manufacturing experience; advanced degree preferred.

• 10-12 years of quality assurance and regulatory compliance experience within the biotech or pharmaceutical industry.

• Proven track record of successfully leading quality initiatives, building, and managing teams in a fast-paced, start-up environment.

• In-depth knowledge of relevant regulations and standards, including GCP and ICH guidelines. GLP or GMP experience a plus.

• Excellent communication and interpersonal skills with the ability to collaborate effectively across different functional areas and levels of the organization.

• Ability to thrive in a dynamic and challenging environment, with a passion for driving innovation and phase-appropriate, sustainable quality compliance

The approximate base salary range for this role is $245,000-$278,000.

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.