Head of Quality
: Job Details :

Base pay range

$120,000.00/yr - $170,000.00/yr

Additional compensation types

Annual Bonus

Location: New York City, New York or Austin, Texas Area

Compensation Range: $120,000 - $170,000 + Bonus

Gameto is seeking a highly experienced and strategic Head of Quality to lead the company's Quality function as we advance our pipeline of cell therapies through clinical development and toward commercialization. This leadership role offers a unique opportunity to shape a modern, phase-appropriate quality organization that supports innovation while ensuring regulatory compliance and operational excellence.

As the Head of Quality, you will oversee internal and external quality systems, including GMP oversight of CDMOs, batch release, audits, and regulatory readiness. If you are passionate about building high-functioning teams, navigating regulatory landscapes, and embedding a culture of quality into a fast-growing biotech company, we encourage you to join us.

About the Role

In this position, you will lead all quality assurance (QA) operations and oversee a robust, scalable Quality Management System (QMS) tailored for advanced biologics and cell therapies. You will act as the primary quality representative with external partners and regulatory authorities, driving continuous improvement, product safety, and compliance across the organization.

We are looking for a leader who combines deep GMP expertise with pragmatic execution, excels in dynamic environments, and thrives on collaboration across cross-functional teams.

Key Responsibilities

As Head of Quality, your key responsibilities will include:

• Leading the overall Quality function, with direct responsibility for internal QA operations and oversight of external CDMOs, CROs, and testing laboratories.
• Serving as the company's primary quality liaison with external partners and regulatory agencies, including during audits and inspections.
• Managing a fit-for-purpose QMS that evolves with Gameto's development pipeline, ensuring readiness for clinical and future commercial activities.
• Overseeing batch record review, lot disposition, and release activities to ensure timely and compliant delivery of product.
• Driving audit readiness, managing internal and external audits, and hosting regulatory inspections (FDA, EMA, etc.).
• Leading and/or approving investigations, including deviations, CAPAs, Out of Specification (OOS) results, change controls, and raw material release decisions.
• Partnering closely with Regulatory Affairs to align on CMC content, inspection readiness, and timely responses to health authority inquiries.
• Championing a culture of quality, risk management, and continuous improvement across all operational areas.
• Providing leadership, mentorship, and organizational development within the Quality team, ensuring alignment with business priorities.

Qualifications

• Bachelor's degree in life sciences, engineering, or a related field is required; advanced degree preferred.
• 5+ years of experience in a Quality leadership role within GMP-regulated biologics or cell therapy environments.
• Extensive knowledge of FDA, EMA, and ICH regulations; experience preparing for and participating in regulatory inspections.
• Proven ability to build, scale, and manage QMS infrastructure in a clinical or early commercial setting.
• Expertise in GMP operations,including deviation management, CAPAs, change control, batch record review, and lot disposition.
• Demonstrated experience with CDMO and vendor oversight.
• Strong communication and leadership skills, with the ability to make timely, informed decisions in high-growth or startup environments.
• A collaborative, hands-on leader with a commitment to excellence and continuous improvement.

How to Apply

If you are excited about shaping the Quality function of a mission-driven biotech company transforming women's health, we welcome your application.

Please apply on LinkedIn and with the following materials together in a single PDF document:

• A cover letter that:
• Highlights your leadership experience in Quality
• Shares your approach to building scalable systems in a fast-growing biotech environment
• Describes your interest in Gameto and anticipated start date
• CV/resume

Why Join Us?

At Gameto, you'll have the opportunity to define and lead a best-in-class Quality organization supporting the development of life-changing cell therapies. As Head of Quality, your work will have a direct and lasting impact on the safety, efficacy, and regulatory success of therapies that aim to transform the landscape of women's healthcare.

About Gameto

Gameto is a pioneering biotechnology company in women's health, co-founded by Dina Radenkovic, a physician-turned-entrepreneur, and Martin Varsavsky, a leader in fertility innovation and founder of the Prelude Network.

With our groundbreaking cell engineering platform—developed through a collaboration with Harvard University's Wyss Institute and Professor George Church's lab at Harvard Medical School—we aim to create treatments for menopause and infertility affecting the female reproductive system. Our scientific approach surpasses traditional therapeutic modalities and sets a new gold standard for research and development in the field.

Backed by $73 million raised in Series A and B funding from Insight Partners, Future Ventures, RA Capital, Two Sigma Ventures, Lux Capital, and others as well as $10 million from ARPA-H, Gameto is committed to transforming women's healthcare through bold innovation.

Read about us in: MIT Technology Review, The New Yorker, The Boston Globe, and Stat News.

Our Values and Commitment to Diversity

At Gameto, we value kindness, collaboration, authenticity, and diversity. We are an equal opportunity employer and are committed to creating an inclusive environment. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Seniority level

Director

Employment type

Full-time

Job function

• Quality Assurance

Industries

• Biotechnology
• Research and Pharmaceutical Manufacturing

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