CAREERS

Associate Director / Director, Quality Assurance

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Job Description:

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Uniquity Bio is seeking a hands-on Associate Director/Director, Quality Assurance to support our growing clinical programs. In this role, the successful candidate will execute the clinical QA strategy at both the program and study level—ensuring GCP/GCLP compliance, audit readiness, and effective quality oversight across all clinical activities.

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This individual will partner closely with Clinical Operations, Regulatory, Biometrics, and CRO partners to maintain a continuous state of compliance and provide practical, real-time quality guidance throughout study start-up, conduct, and closeout.

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This is an excellent opportunity for a QA professional who thrives in a fast-paced biotech environment, values collaboration and transparency, and wants to make a meaningful impact on clinical quality and organizational readiness.

 

Qualifications:​

• 10+ years of GCP Quality Assurance experience

• Strong expertise in auditing, CAPA management, and inspection readiness

• Solid knowledge of FDA regulations, ICH GCP guidelines, and clinical quality systems

• Demonstrated ability to collaborate effectively across cross-functional teams and external partners

• Strong interpersonal and communication skills, with the ability to influence and build trust

• Excellent organizational skills, sound judgment, and attention to detail in a dynamic environment

• A proactive, solutions-oriented mindset with the ability to work independently and as part of a team​

 

Required Skills, Abilities and Behaviors:

• Execute the annual clinical audit plan and lead vendor and site audits

• Maintain continuous inspection readiness across clinical programs

• Lead investigations and drive effective CAPA implementation

• Provide strong vendor and study team oversight

• Promote a culture of quality and strengthen GCP understanding across clinical teams

• Communicate quality expectations clearly with internal and external stakeholders

• Build productive relationships across clinical, regulatory, and operational teams

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