Advarra

Quality Assurance – Manufacturing, GMP, CMC, Aseptic

Advarra

part-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

SeniorLead

About the role

  • 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 (in-transit and storage)
  • 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
  • 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 verbal and written communication skills in English required
Benefits
  • Health insurance
  • Flexible work arrangements
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assurance managementaseptic processingcleanroom operationsaseptic techniquescontamination controlregulatory complianceenvironmental monitoringGood Manufacturing PracticesChemistry, Manufacturing, and Controlsquality risk assessments
Soft Skills
strong verbal communicationstrong written communication