Quality Assurance – Manufacturing, GMP, CMC, Aseptic

Job not on LinkedIn

🕒 March 27

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Advarra

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1983

☁️ SaaS

🤖 Artificial Intelligence

Healthcare • SaaS • Artificial Intelligence

Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.

📋 Description

• Approve the final quality of Investigational Medicinal Products (IMPs) • Review and approve compliance with all mandatory requirements, including Manufacturing Batch Records, Environmental Monitoring (EM), Media Fills, deviations/violations/out-of-specification (OOS) events and corrective and preventive actions, packaging and labeling, drug release, distribution, and temperature control • Lead and manage all quality-related communications with regulatory authorities • Explain the sponsor’s quality system and release decision processes during regulatory inspections (e.g., EMA, FDA) • Provide scientific justification for the sterile product risk management framework within the Contamination Control Strategy (CCS) in accordance with Annex 1 • Ensure compliance with the Pharmaceutical Quality System (PQS) according to International Council for Harmonisation (ICH Q10) guidelines • Provide appropriate quality oversight of Contract Manufacturing Organizations (CMOs) • Approve change controls and Corrective and Preventative Actions (CAPAs) • Conduct quality risk assessments

🎯 Requirements

• Minimum 10 years of Quality Assurance Management • Demonstrated experience managing quality for aseptic processing for a Pharma/Biotech or Contract Manufacturing Organization (CMO) • Experience performing cleanroom operations, aseptic techniques, contamination control, regulatory compliance, and environmental monitoring • Good Manufacturing Practices/Chemistry, Manufacturing, and Controls (GMP/CMC) expertise • Experience in critical risk assessment • Strong interpersonal and client-facing skills • Strong verbal and written communication skills in English required

🏖️ Benefits

• Registration with Advarra’s Expert Network required for consideration • Inclusive and collaborative environment • Empathy and care as key tenets of company culture • Commitment to creating a workplace where each person is valued