QUALITY ASSURANCE SPECIALIST

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:

The Quality Assurance Specialist is responsible for supporting quality and compliance activities within clinical trials. This role plays a critical part in ensuring patient safety, data integrity, and adherence to regulatory guidelines and Good Clinical Practice (GCP) standards. The QA Specialist will assist with documentation, audit coordination, issue tracking, and ongoing quality assurance initiatives to strengthen the compliance framework of clinical research activities.This position will report to the Senior Director, GxP QA.

This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Quality Oversight & Metrics: Analyze, track, and report on quality metrics to identify trends, ensure compliance, and support continuous improvement.

CAPA & Quality Event Management: Support the full lifecycle of corrective and preventive actions (CAPAs) arising from audits and quality events, including tracking, follow-up, root cause analysis, effectiveness checks, and reporting to QA leadership.

Audit Support & Program Management: Assist with preparation, coordination, and follow-up for internal, external, and regulatory audits. Support resource planning, scheduling, and communication for audit activities, and contribute to the development and maintenance of the Master Audit Schedule (MAS). Collaborate with auditors to ensure timely execution of audit tasks.

eQMS Documentation & Records: Record and maintain accurate data in the electronic Quality Management System (eQMS), including audits, deviations, risks, CAPAs, and other quality events.

Risk Management: Contribute to risk assessments, ensure accurate risk log entries, and support proactive risk mitigation activities.

SOPs & Continuous Improvement: Participate in SOP reviews and updates and contribute to quality system enhancements with minimal oversight.

General QA Support: Provide assistance with additional quality assurance responsibilities as needed to strengthen overall quality systems.

QUALIFICATIONS

• 2+ years of GCP QA, clinical operations or clinical research experience is preferred.
• Strong attention to detail and accuracy in documentation.
• Data analytics knowledge with the ability to interpret and present findings.
• Strong communication skills and ability to work cross-functionally.
• Excellent organizational and time management skills.
• Ability to travel approximately 10–15%.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $95,000 - $105,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.