At HAYA Therapeutics, we are revolutionizing RNA-guided genome-targeting therapies to treat fibrosis, heart failure, and other serious chronic diseases associated with aging. Our innovative platform leverages long non-coding RNAs (lncRNAs) - key regulators within the “dark matter” of the genome - to develop first-in-class, highly specific therapies that reprogram disease-driving cell states into a healthy and resilient state, tackling disease at its roots.
Following the successful close of our Series A financing, HAYA is well-positioned to advance our pipeline and execute on key scientific and operational milestones, including the advancement of HAYA’s lead program, HTX-001, toward the clinic for the treatment of non-obstructive hypertrophic cardiomyopathy (nHCM). In recognition of our scientific innovation and potential global impact, we have been named one of the 100 early-stage companies selected for the World Economic Forum’s 2025 Technology Pioneers.
As a fast-growing biotech, we offer an entrepreneurial, science-driven environment where you’ll have a direct impact on shaping our programs and advancing the future of RNA medicine.
Role Summary
HAYA Therapeutics is seeking a strategic, execution-focused Director of Quality & Processes to design, implement, and lead the company’s Quality Management System (QMS) and operational frameworks. As HAYA’s dedicated quality and process hire, you will play a pivotal role in embedding a culture of quality, compliance, and operational excellence across the organization.
This high-impact, individual contributor role sits within the Operations team and serves as a critical integrator - translating strategy into scalable systems, reinforcing delivery discipline, and building the documentation infrastructure needed to support organizational transparency, audit readiness, and cross-functional execution.
You will be responsible for establishing a fit-for-purpose QMS and operational process architecture that supports risk management, audit preparedness, supplier quality, and controlled documentation, aligned with both regulatory expectations and the evolving needs of a fast-paced biotech advancing toward scale.
In parallel, the Director will contribute to the company’s Audit Committee mandate by strengthening operational risk oversight, ensuring that business processes are clearly defined and documented.
This is a rare opportunity for a hands-on, systems-minded leader to shape foundational quality and operational processes that will enable HAYA to grow with precision, integrity, and confidence.
What’s in it for me?
At HAYA, this isn’t a typical Director of Quality role—it’s a rare opportunity to shape how quality and operational excellence evolve in a high-growth biopharma. You’ll have significant latitude to design and lead systems that align with scientific ambition, regulatory expectations, and real-world execution needs.
What makes this role unique:
- Ownership with Autonomy: Drive the strategy and structure of HAYA’s QMS and process frameworks.
- Early-Stage Impact: Influence how quality scales across programs and geographies.
- Purpose-Driven Science: Contribute to precision RNA medicines for complex, common, and chronic diseases.
- Executive Collaboration: Work side-by-side with senior leadership on high-priority initiatives.
If you’re looking for a career-defining role where you can lead, innovate, and leave a lasting mark, HAYA offers the platform and trust to make it happen.
Key Responsibilities
1. Quality Systems and Documentation Governance
- Design and maintain a fit-for-purpose Quality Management System (QMS) covering controlled documents, internal SOPs, and quality assurance processes.
- Ensure quality documentation is audit-ready, up to date, and aligned with best practices across GxP-adjacent operations.
- Lead periodic internal reviews and quality spot-checks; manage CAPA resolution in collaboration with functional owners.
2. Process Design & Operational Clarity
- Map, standardize, and optimize business-critical processes across operations, science, clinical support, and vendor interactions.
- Lead the implementation and execution of HAYA’s Good Clinical Practice (GCP) Quality Management System, writing and approving documents to ensure alignment with regulatory expectations and industry best practices.
- Partner with department heads to define operating procedures that support efficiency, compliance, and scalable growth across functions.
- Manage supplier qualification and oversight for third-party manufacturers, including the development and maintenance of Quality Agreements to ensure compliance and accountability.
- Provide cross-functional teams with templates, workflows, and onboarding tools that embed process consistency without unnecessary complexity.
3. Executive Operations and Governance Support
- Support the design and implementation of the operational forums that support decision-making, follow-through, and transparency (e.g., program reviews, operational steering, milestone tracking, etc.).
- Support the COO and functional leaders with structured reporting tools and data dashboards aligned to company KPIs and governance needs.
- Has accountability for documentation and inputs for leadership and Audit Committee reviews as appropriate.
4. Change Enablement and Continuous Improvement
- Act as a process ambassador, helping teams adopt new systems through enablement, documentation, and toolkits.
- Identify and remediate operational inefficiencies or inconsistencies across functions.
- Maintain repositories and versioning systems that enable accessible, auditable documentation control.
Qualifications
Education
Bachelor’s or advanced degree in Life Sciences, Quality, Engineering, or a related operational discipline
Experience
- Required: Experience building and leading a quality and process management function in a startup-to-scale-up environment, including readiness for financial and operational due diligence processes tied to investor reviews, partnerships, or exits.
- 10+ years in operational quality, documentation systems, or business operations in biotech, medtech, or regulated innovation industries.
- Strong track record of cross-functional collaboration, audit interfacing, and quality infrastructure design.
Skills
- Strong fluency in documentation systems, process design, and project management abilities.
- Strong facilitation and cross-functional alignment capabilities.
- Detail-oriented with a practical, solution-oriented mindset.
- Able to support governance and leadership reporting with clarity and discretion.
What Success Looks Like
- A lean, scalable QMS and documentation system is embedded and trusted across functions.
- Executive and Audit Committee forums operate with clarity, inputs, and reporting consistency.
- Operational risks are mapped, reviewed, and proactively mitigated.
- Functional leaders are confident in navigating audit requests and can access required documentation with ease.
- Teams experience smoother collaboration, faster onboarding, and better decision tracking due to structured process support.
HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development.
At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.
