Senior Quality Assurance Specialist

About Aerogen Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination products. At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life‑threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients. We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities. Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries. What is the role? The Senior Quality Assurance Specialist provides laboratory-focused, risk-based Quality oversight of analytical testing, microbiology, stability programs, laboratory investigations and data integrity supporting Aerogen Pharma’s clinical-stage drug and drug-device combination products. The role serves as a key QA partner to internal and external contract testing laboratories and CDMOs, while also supporting GMP manufacturing, batch review and disposition, supplier management, quality systems and inspection readiness. The Specialist independently reviews complex quality records and helps ensure that laboratory and manufacturing data are scientifically sound, reliable, traceable and suitable for regulatory submissions and clinical supply decisions. What are the key responsibilities? Laboratory Quality Oversight and Data Review Provide QA oversight of in-house and outsourced analytical, microbiological, release, in-process and stability testing performed by contract testing laboratories and CDMOs, including testing of raw materials, intermediates, drug product and combination-product components, as applicable. Independently review analytical and microbiological test records, raw data, calculations, chromatograms, audit trails, laboratory notebooks, Certificates of Analysis (CoAs) and supporting documentation for scientific integrity, completeness and GMP compliance. Review laboratory methods, specifications, sampling plans, method qualification/validation, method transfers and laboratory equipment qualification or computerized system validation documentation within assigned QA authority. Provide QA review of sterility, bioburden, endotoxin, environmental monitoring and other microbiological testing and associated investigations, as applicable to the product and testing strategy. Evaluate laboratory controls, reference standards, reagents, sample handling, chain of custody, instrument calibration, system suitability and good documentation practices as relevant to data reliability. Laboratory Investigations, Deviations and CAPA Lead or independently review and approve laboratory deviations, out-of-specification (OOS), out-of-trend (OOT), atypical results, invalidated tests and data integrity events. Assess laboratory investigation scope, hypothesis testing, assignable cause, root-cause analysis, retesting/resampling justification, product impact and potential implications for clinical materials or regulatory data. Review CAPAs, corrective actions, laboratory change controls and effectiveness checks; promote timely, scientifically justified and well-documented resolution with external laboratories and internal technical teams. Stability, Specifications and Product Quality Provide QA oversight of stability protocols, sample pulls, analytical results, trending, excursions and stability reports, including assessment of potential impacts on shelf life, expiry or retest dating. Review proposed specifications, analytical acceptance criteria, method changes and laboratory trends in collaboration with CMC, QC and Regulatory Affairs. Review testing packages and CoAs to support incoming material acceptance, batch release, clinical supply disposition and quality decisions within established approval authority. Manufacturing, Packaging and Supply Quality Oversight Maintain risk-based QA oversight of outsourced compounding, filling, aseptic processing, packaging, labeling, storage, shipment and relevant validation activities, as applicable. Review executed manufacturing, packaging and labeling batch records, deviations, process controls, cleaning and sterilization records and related documentation to support batch disposition and clinical supply readiness. Evaluate manufacturing and warehouse quality events, change controls, material holds, shipment-under-quarantine documentation and supplier-related quality issues in collaboration with CDMOs and cross-functional teams. Quality Systems, Supplier Management and Inspection Readiness Review and approve SOPs, laboratory quality records, change controls, risk assessments, deviations, CAPAs and validation documents; support phase-appropriate GMP. Oversee quality performance of contract testing laboratories, CMOs/CDMOs and critical suppliers through documentation review, quality agreement adherence, metrics, audits and remediation follow-up. Apply ALCOA+ data integrity principles to LIMS, ELN, eQMS, eDMS and manual and/or electronic batch records, including appropriate review of audit trails, access controls and electronic records. Support GMP audits, regulatory inspections, inspection responses, and laboratory/CMC portions of regulatory submission packages, as requested. Collaborate with QC, Regulatory Affairs, Manufacturing, Supply Chain, Engineering and device partners to identify and mitigate product-quality risks and drive practical continuous improvement. What key skills will make you great at the role? Strong technical understanding of analytical and microbiological laboratory practices, scientific data review, method performance and laboratory compliance. Sound judgment in evaluating OOS/OOT investigations, laboratory data integrity, stability trends, product impact and batch disposition readiness. Excellent technical writing, root-cause analysis, risk assessment and CAPA effectiveness review skills. Ability to provide pragmatic oversight of external testing and manufacturing partners and to influence decisions. Strong knowledge of GMP, Good Documentation Practices, ALCOA+ and electronic laboratory/Quality systems. Collaborative, detail-oriented and organized, with the ability to balance laboratory priorities and broader operational Quality responsibilities in a clinical-stage environment. Candidates may be based in San Mateo, California or Morrisville, North Carolina. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high-performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged. Equal Employment Opportunity Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law. Salary Range and Benefits Salary Range for this position is estimated at $88,000-$105,000 and will depend on the candidate's skills, qualification and experience. The role is eligible for a performance-based incentive bonus and comprehensive benefit package including Medical, Dental, and Vision Coverage, 401k Retirement, Enhanced Global Life Insurance, Paid Time Off (15-20 days tenure related), Global EAP Program, Short-Term Disability and FMLA Benefits. The company reserves the right to adjust this pay range at any time. Job Title Senior Quality Assurance Specialist Experience City Candidates based in either San Mateo, California or Morrisville, North Carolina will be considered for this role. Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications. #J-18808-Ljbffr Aerogen Ltd.