Quality Assurance Manager

About LeonaBio:


LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for high unmet medical needs, including amyotrophic lateral sclerosis (ALS) and treatment-resistant metastatic breast cancer, with the goal of improving patients' lives. Our lead drug candidates, lasofoxifene and ATH-1105, are novel, small molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. With a strong commitment to scientific excellence and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most.


About this role:


The Quality Assurance Manager plays a critical role in supporting and strengthening LeonaBio's Quality Assurance function. Reporting directly to the Senior Director of Quality, this role ensures the integrity, consistency, and continuous improvement of quality systems across the organization. The ideal candidate brings strong analytical skills, a proactive mindset, and the ability to partner effectively with cross-functional teams to uphold high standards of quality and compliance.


Responsibilities:

• Lead QA support and provide strategic quality oversight for outsourced cGMP operations related to the manufacture of drug product used in clinical trials.

• Lead the review of executed batch records and ancillary documentation to ensure accuracy, completeness, compliance with approved procedures, and readiness for disposition decisions.

• Oversee and perform product disposition activities for clinical trial materials, ensuring decisions are well documented, risk-based, and aligned with quality and regulatory expectations.

• Provide QA review and approval for Master Batch Records, protocols, reports, and SOPs, ensuring alignment with internal standards, phase-appropriate regulations, and operational needs.

• Support and help coordinate computer system validation activities as needed to maintain compliant and effective quality-related systems.

• Lead the QA review of deviations, product non-conformities, and other investigations to ensure robust root cause analysis, timely resolution, and sustained compliance.

• Oversee CAPA review and closure activities, ensuring proposed actions are appropriate, effectively implemented, and supported by meaningful effectiveness checks.

• Provide oversight of change controls and periodic reviews of controlled documents to ensure changes are appropriately assessed, approved, and implemented within the quality system.

• Support oversight of the training program to help ensure training assignments, completion, and compliance are maintained across applicable quality processes.

• Author, revise, and approve quality documentation as needed, while driving clarity, consistency, and compliance across documentation practices.

• Analyze and report quality-related metrics to identify trends, inform risk-based decisions, and support continuous improvement initiatives.

• Support regulatory audits and inspections by helping prepare the organization, coordinating quality inputs, and assisting with timely follow-through on observations and commitments.

• Support the external audit process by scheduling, preparing, and performing GCP, GCLP, GLP, and GMP supplier audits with follow-through on completing the audit report and receiving a timely response, as applicable, from the supplier.

• Support the internal audit process by scheduling, preparing, and performing, or supporting, the audit while assisting with timely follow-through for audit reports and/or responses.

• Contribute to additional quality and cross-functional initiatives, special projects, and operational priorities as assigned.

Requirements:

• Bachelor's degree in a life science field.

• Minimum of 5 years of experience in the pharmaceutical industry plus working knowledge and understanding of GxPs for drugs in development.

• Experience performing GCP, GCLP, GLP, and GMP audits a plus.

• Ability to maintain attention to detail, prioritize work, and handle multiple assignments in a fast-paced environment.

• Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.

• Ability to adapt the work schedule to participate in teleconferences with CDMOs and CROs in different time zones.

• Must have excellent verbal, written, and organizational skills.

• Must have excellent leadership and interpersonal skills with the ability to effectively interact and influence different functional groups at all levels of management.

• Experience with Veeva and SharePoint a plus.

• Travel within the US will be required on occasion. Travel outside of the US may be required.
• Must be authorized to work in the United States; visa sponsorship is not available for this role

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual's race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.