Remote Quality Assurance Manager Jobs in Bothell, WA

AboutLeonaBio:

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,lasofoxifeneand 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 QualityAssurance Managerplays a critical role in supporting and strengtheningLeonaBiosQuality Assurance function. Reporting directly totheSenior 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 crossfunctional teams to upholdhigh standardsof quality and compliance.

Responsibilities:

• Lead QAsupportandprovidestrategic quality oversight for outsourced cGMP operations related to the manufacture of drugproductused 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 tomaintaincompliant and effective quality-related systems.

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

• Oversee CAPA review and closure activities, ensuring proposed actions areappropriate, 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 aremaintainedacross 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 toidentifytrends, inform risk-based decisions, and support continuous improvement initiatives.

• Support regulatory audits and inspections by helping prepare the organization, coordinating quality inputs, andassistingwithtimelyfollow-through onobservations and commitments.

• Support theexternal audit process by scheduling, preparing, and performing GCP, GCLP, GLP,and GMP supplier auditswith follow-through oncompleting the audit reportandreceivinga timelyresponse, as applicable, from the supplier.

• Support the internal audit processbyscheduling, preparing, and performing, or supporting, the auditwhileassistingwithtimelyfollow-throughfor audit reports and/or responses.

• Contribute toadditionalquality and cross-functional initiatives, special projects, and operational priorities as assigned.
  

Requirements:

• Bachelors degree ina lifescience field.

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

• Experience performing GCP, GCLP, GLP,and GMPauditsa plus.

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

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

• Ability toadaptthe work schedule toparticipatein teleconferences with CDMOsand CROsin 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 andSharePointa plus.

• Travel within the US will berequiredon occasion.Travel outside of the US may berequired.
• 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 individuals 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,conditionsand privileges of employment, including recruitment, hiring, placement, compensation, promotion,disciplineand termination.