Director/Senior Director, Quality Assurance at Tenaya Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

240000.0

Posted On

02 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GxP Compliance, Risk Management, Audit Management, Regulatory Interactions, Stakeholder Management, Cross-Functional Influence, Quality Management Systems, Data Integrity, Inspection Readiness, Clinical Development, Biologics, Gene Therapy, Quality Control, CAPA Implementation, Document Control

Industry

Biotechnology Research

Description

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. 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 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 Preferred 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. Key Competencies Strong stakeholder management and cross-functional influence Ability to operate effectively in a lean, fast-paced environment Sound judgment with a pragmatic, risk-based approach to quality Excellent communication skills, including ability to convey complex quality topics to non-experts Tenaya takes into account a wide range of factors when determining compensation including not limited to skill sets, experience, interview performance and organizational need. We will make an offer based on geo-located salary bands based on data collected from Aon/Radford. As of 1/1/2023, for individuals assigned and/or hired to work in the San Francisco Bay Area in the state of California, your base salary will fall within the band(s) below. This base salary range is an estimate, and the actual base salary may vary based on Tenaya’s compensation practice. Please also keep in mind that the benefits, bonus, and the equity portion of your offer is not included in these numbers and represents a significant portion of your total rewards package at Tenaya. Should you reach the verbal offer stage of Tenaya’s hiring process, we will review the base salary, benefits, bonus target and equity grant value with you at that time. The salary for the Director/Senior Director, Quality Assurance position is $240,000+ dependent on experience. 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. Tenaya is proud to be an equal opportunity workplace.

Responsibilities

The Director/Senior Director, Quality Assurance will provide strategic quality leadership for clinical-stage programs, ensuring GxP compliance across various activities. This role includes oversight of external partners and maintaining quality management systems.