Manager, Quality Assurance

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 140 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.

The Manager, Quality Assurance facilitates processes for change control, deviation, Out Of Specification results, Corrective Action and Preventive Action, quality metrics reporting, and training systems, support internal/external supplier, regulatory inspection as needed. The Manager, Quality Assurance will also support manufacturing processes as the person-in-plant (PIP) and the technical reviewer for executed batch records and associated supporting documents, and work closely with Quality Control, Manufacturing, Product Development, Engineering, and Facilities departments to ensure the compliance of cGMP.

Responsibilities

• Account for the maintenance and development of Tenaya’s Quality System and the management of quality and compliance activities.
• Ensure the maintenance and management of electronic data management (Veeva), training systems (LMS), and accompanying Quality IT systems.
• Creating, reviewing, approving, and archiving company standard operating procedures, product specifications, analytical methods, forms, protocols and reports, master batch records, etc.
• Manage training system and training records, work with department heads to develop training curriculum for all GxP personnel and conduct annual GMP refresh training.
• Review QC release and stability documentation, including Certificates of Analysis, stability reports, etc.
• Provide oversight of potential client activities including executed master batch record review, lot disposition, etc.
• Work with third party logistics and the Qualified Person to ensure lot release and certification.
• Manage quality agreements and supplier quality documentation.
• Other responsibilities may be assigned.

Requirements

• Bachelor’s degree in scientific discipline or health-related field.
• 7 – 10 years of experience in quality operations or development in the biotechnology or pharmaceutical industry.
• Experience as superuser of electronic quality systems strongly preferred.
• In depth knowledge of FDA regulations, 21 CFR Part 11, 210, 211, 600.
• Working knowledge of ICH Quality Guidelines.
• Strong organizational skills and attention to detail.
• Strong ability to prioritize, multi-task, and work in an evolving environment.
• Self-motivated, able to function independently with minimal supervision in a fast-paced start-up team environment.
• Excellent presentation and written/verbal communication skills.

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 Manager, Quality Assurance range is $120,000 to $140,000.

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.