QA Systems Manager

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

Position Summary

This position supports GMP quality assurance systems for the company’s biologics products and research. This role summarizes product disposition status, provides QA input for product release and review, and manages the compilation and review of product disposition and release records of all clinical products at Day One. The role is also responsible for implementing, and managing quality assurance programs to ensure compliant quality systems. This role reports to the Senior Director, QA.

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

Essential Duties And Responsibilities

• Ensures batch record packages are complete prior to presenting to QA management for disposition.
• Work with CMC development team to implement phase appropriate biologic deliverables such as Master Batch records, analytical methods and specifications.
• Performs Quality Assurance (QA) Batch Review for clinical batches.
• Performs QA batch review for SOC (comparator) activities.
• Performs QA batch review for packaging and labeling activities and overlabeling activities.
• Provides support during inspection readiness activities as needed.
• Identifies common and frequent issues for auditing purposes from CMOs.
• Ensure compliance with industry standards and business requirements.
• Manages and provides documents for Qualified Person release in support of global clinical trials.
• Supports quality assurance systems as needed and directed by management.

Qualifications

• BS, or advanced degree, in life sciences or relevant field. Masters, PharmD, PhD or equivalent is a plus.
• 4+ years of QA experience in the biopharmaceutical and/or biologics industry; Antibody Drug Conjugate experience preferred.
• Demonstrated understanding of GMP regulations, processes, and issues in biologics manufacturing. Includes sound knowledge of ICH and regional requirements and other relevant guidelines.
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat.
• Self-motivated and flexible team-member, able to prioritize, multi-task and ability to ‘think outside the box’ in a fast-paced environment.
• Demonstrated management of compliance activities and processes with a proven track record of effective collaboration with regulatory agencies, including the FDA.
• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
• Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others; prior management experience a plus.
• Outstanding attention-to-detail.
• Familiarity of the multidisciplinary functions involved in pharmaceutical/biotechnology product development.
• Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.

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 $120,000 - $140,000. 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.