Quality Assurance Manager

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🕒 vor 2 Tagen

☕ Washington – Remote

☕ Washington – Remote

💵 $130.000 - $145.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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LeonaBio

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

🏥 Gesundheitswesen

💰 €103.500.000 Post IPO equity im 2021-02

Biotechnology • Pharmaceuticals • Healthcare

LeonaBio ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger niedermolekularer Therapien für schwerwiegende Krankheiten mit begrenzten Behandlungsmöglichkeiten konzentriert. Zu den führenden Kandidaten gehören Lasofoxifen und Brelgometon (ATH-1105), und das Unternehmen führt klinische Studien durch, um Sicherheit und Wirksamkeit zu bewerten, als Teil seiner Mission, die Patientenversorgung zu verbessern. LeonaBio ist in den Bereichen Medizin und Patientenarbeit tätig und hat kürzlich ATH-1105 auf einem ALS-Arzneimittelentwicklungsgipfel präsentiert, was auf eine Beteiligung an der Forschung zu neurodegenerativen Erkrankungen hinweist.

Beschreibung

• 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.

🎯 Anforderungen

• 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.