Associate Director Quality Assurance

About Us:

How many pills per day would you consider a lot?five? Maybe ten? For dialysis patients, it?s often much higher, with an average of 19 pills daily. At Unicycive, we?re committed to developing innovative treatments for kidney disease, including OLC, our investigational lead drug candidate for hyperphosphatemia in Chronic Kidney Disease (CKD) patients on dialysis. Designed to reduce pill burden with fewer, smaller, easy-to-swallow tablets, OLC has the potential to improve treatment adherence and patient outcomes if approved.

With our NDA filing for OLC under review by FDA, we anticipate potential approval in June and a commercial launch in the second half of 2025. Beyond OLC, we?re advancing a pipeline of therapies to address critical gaps in kidney disease treatment.

At Unicycive, we put people first?both patients and our team. Our collaborative culture champions diverse voices, tenaciously pursues big ideas and empowers each other to make an outsized impact. We are headquartered in Los Altos, CA, but our employees are largely remote-based. Come and be part of a company transforming kidney care. Learn more at www.unicycive.com.

Position Overview:

The Associate Director of Quality Assurance will lead and oversee the development and implementation of GXP quality systems. This role ensures compliance with global regulatory requirements, including ICH, FDA, EMA, and other competent authority guidelines, while supporting the organization?s quality and operational objectives. The successful candidate will drive quality oversight for internal operations and external partners, ensuring readiness for inspections and maintaining the highest standards of compliance.

Key Responsibilities:

Quality Systems Development and Oversight:
? Design, implement, and manage GXP, including GMP quality systems, to meet global regulatory requirements and industry best practices.
? Develop and manage quality management systems (QMS), covering vendor management, change control, risk management, deviation and CAPA systems, product label reviews, and GXP computer systems.

Document and Compliance Management:
? Review and approve GXP documents and reports, particularly those related to material specifications, method development, and validation activities.
? Perform batch record review and product release activities to ensure all products released meet regulatory standards
? Provide compliance oversight for both internal operations and contracted external GXP activities.

Audits and Vendor Oversight:
? Develop and execute audit plans and reports for CROs, CDMOs, GMP vendors, and internal departments.
? Conduct virtual and on-site audits as required and ensure findings are addressed with appropriate CAPAs.
? Oversee GMP CDMOs, including quality agreements and batch record review and disposition of GMP products.

Inspection Readiness and Hosting
? Lead inspection readiness activities for internal and external entities to ensure preparedness for regulatory inspections.
? Host GMP inspections and manage follow-up actions, including responses and CAPA implementation.

Training and Reporting:
? Develop and implement GXP training programs, ensuring all employees, including contractors, are appropriately trained.
? Monitor and report on GXP strategy performance metrics, analytics, and compliance trends.

Requirements:

Education
? Bachelor?s degree in Chemistry, Biochemistry, or a related field; advanced degree preferred.

Experience, Skills and Competencies
? Minimum of 8 years? experience in a pharmaceutical or biotechnology setting.
? Extensive knowledge of global GXP regulatory requirements, GMP regulations, and current industry practices.
? Experience with eQMS and validation of software solutions.
? Demonstrated expertise in designing and implementing quality systems and risk management tools.
? Experience managing CMOs for drug substance (DS) and drug product (DP) and leading regulatory inspections.
? Strong interpersonal, verbal, and written communication skills in a collaborative work environment.
? Proven organizational and project management skills with the ability to prioritize in a fast-paced, dynamic environment.
? 20-30% travel

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