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Location

This role is open to consultants working remotely in the United States.

Company Information

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.

Company Culture

Our people--both employees and consultants--are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

Job Overview Summary

Advarra is seeking a Quality Consultant with hands-on experience managing quality for aseptic processing for a Pharma/biotech or a Contract Manufacturing Organization (CMO). This position will be 40 hours per month, an average of 10 hours per week, for approximately 2 years with an option for an extension.

Job Duties & Responsibilities

• 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.

Basic Qualifications

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

Equal Opportunity Employer
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