Consultant, Clinical Quality Assurance – Early Access Programs

🔥 6 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 15%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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SAVARA

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Savara is a clinical-stage biopharmaceutical company focused on developing treatments for rare respiratory diseases, principally autoimmune pulmonary alveolar proteinosis (aPAP). Their lead product candidate, MOLBREEVI (molgramostim inhalation solution), is an inhaled recombinant GM-CSF currently in Phase 3 development for aPAP; the company maintains clinical programs, medical affairs, patient resources, and investor relations activities related to advancing this therapy. Savara conducts clinical trials, engages with investigators and patient advocacy organizations, and provides information on diagnostics, expanded access, and regulatory status.

📋 Description

• Support quality oversight and management of Good Clinical Practices (GCP) activities related to the Early Access Program • Provide Clinical Quality Assurance leadership and subject matter expertise to the EAP Team • Perform vendor gap assessments and identify remediation plans • Assess the medical review process for proper documentation • Provide strategy and execution for the anticipated transition of patients to commercial product, depending on Health Authority approval • Generate and coordinate timely quality event management documentation, including CAPA plans as necessary • Author, revise, and maintain QA Standard Operating Procedures • Provide QA subject matter expertise for reviews of clinical protocols, amendments, informed consent forms, and related regulatory submission documents • Plan, conduct, and/or assist with internal and external service provider audits • Review audit reports and associated corrective and preventative actions • Identify risks, resolve issues, and escalate appropriately • Work as a member of the Early Access Program Team to drive strategy and execution

🎯 Requirements

• Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise • Experience with Good Clinical Practices (GCP) activities • Previous experience providing GCP QA oversight to Early Access Programs (EAPs) strongly preferred • Experience with vendor oversight and gap assessments • Knowledge of medical review documentation processes • Experience with quality event management, including corrective action and preventive action (CAPA) plans • Experience authoring, revising, and maintaining QA Standard Operating Procedures (SOPs) • Experience reviewing clinical protocols, amendments, informed consent forms, and regulatory submission documents • Experience planning, conducting, or assisting with internal and external service provider audits • Ability to review audit reports and corresponding corrective and preventative actions for adequacy • Must be located within the United States

🏖️ Benefits

• Consultant contract expected to be 120–170 hours per month for 12 months • Remote work within the U.S.