Director/Senior Director, Quality Assurance

Tenaya Therapeutics • South San Francisco, CA

8h • $240,000

About The Position

Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development.
Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 70 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak – the delivery of new therapies for heart disease to the patients who need them.
For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.
Diversity & Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.
Position Summary
Tenaya Therapeutics is seeking a Director or Senior Director, Quality Assurance (QA) to provide strategic, phase-appropriate quality leadership in support of Tenaya’s clinical-stage programs. This role is responsible for ensuring GxP compliance across GMP, GCP, and GLP activities through a risk-based, highly outsourced operating model.
The position will serve as a key cross-functional partner, providing independent QA oversight across internal teams and external partners, including CROs, CMOs, and other vendors. This individual will play a critical role in inspection readiness, quality systems governance, and driving fit-for-purpose quality processes aligned with Tenaya’s current stage and business priorities.
This role is focused on GxP Quality Assurance and Quality Control (QC) oversight and systems.

Requirements

• Bachelor's degree (or higher) in a scientific discipline
• Director: ~8+ years; Senior Director: ~12+ years of relevant experience in Quality Assurance within biotechnology or pharmaceutical environments
• Strong working knowledge of GxP requirements (GMP, GCP, GLP) in a clinical-stage setting
• Experience operating in a highly outsourced development model, with demonstrated oversight of CROs, CMOs, and other vendors
• Proven experience leading GxP audits, inspection readiness, and regulatory interactions
• Demonstrated application of risk-based quality management principles

Nice To Haves

• Experience supporting complex biologics or gene therapy programs, lab experience
• Experience in early to mid-stage clinical development (Phase I/II)
• Prior experience scaling or right-sizing quality systems in a resource-constrained environment
• Prior hands-on lab experience with Quality Control release/stability testing would be helpful.

Responsibilities

• Provide independent GxP QA oversight across GMP, GCP, and GLP activities in support of clinical development programs
• Oversee quality activities performed by external partners, including CROs, CMOs, CDMOs, and contract laboratories
• Establish and maintain Quality Agreements to ensure clear roles, responsibilities, and compliance expectations
• Lead and manage the GxP audit program (internal and external), including vendor qualification and ongoing oversight
• Maintain and continuously improve phase-appropriate, fit-for-purpose Quality Management Systems (QMS)
• Oversee eQMS processes including document control, change control, deviations, CAPAs, complaints, and batch disposition
• Ensure data integrity and compliance through QA oversight of activities conducted by internal teams and external vendors
• Disposition (approve/reject) clinical batches in accordance with regulatory requirements
• Lead inspection readiness strategy and execution for FDA (including CBER) and other global regulatory inspections
• Serve as the primary Quality representative during regulatory inspections and audits
• Lead response development for regulatory observations, including root cause analysis and CAPA implementation
• Implement risk-based QA approaches to prioritize oversight across development activities
• Conduct targeted quality risk assessments across programs and functions
• Communicate quality risks, trends, and mitigation strategies to senior leadership

Benefits

• We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.
• We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.
• State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
• Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees