Madrigal Pharmaceuticals

Senior Manager, GCP Quality Assurance

PA - Pennsylvania – Remote, USA · Senior · Full-time

Sponsorship not specified$147k-$180kDetected 27 days ago

GCPStatisticsAuditingProcess ImprovementClinical TrialsFDA RegulatoryPharmacovigilanceMentoring

About the role

This position will be responsible for GCP/Clinical Quality Assurance activities.
The primary responsibilities will be to ensure quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices.
This position reports into the Senior Director, GCP Quality

Attend routine internal and external clinical study team and ad hoc calls in support of ongoing quality oversight
Onboard, coordinate and/or manage services provided by external quality auditing partners (planning to closeout)
Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines
Conduct or manage internal/external audits (clinical trial vendor, site, TMF, document, internal process) and prepare or review audit reports
Lead reviews, manage documentation, track and/or follow-up on Observations/Findings, CAPAs, Quality Event investigations, deviations, etc. through to closure
May lead quality investigations (QEs), including potential Serious Breach, Fraud/Misconduct, etc.
Support use of the eQMS via data entry/document upload of quality activities (audits, Findings/Observations and responses, inspections, CAPAs, SOP Deviations and updates, QEs/Investigations)
May develop, implement, and/or maintain clinical quality systems and processes to ensure compliance with ICH GCP, FDA, EMA, and other global regulatory requirements
Vendor and External Partner Quality Management
Review key clinical program or study documents, such as IBs, Protocols/Amendments, Consents, TMF Plans

Minimum 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry, to include auditing of clinical trial vendors, sites and/or TMFs or internal R&D process audits
Minimum 3-5 years of experience in a clinical operations role at a CRO or Sponsor, to include management of a study at a cross-functional level
Demonstrated GCP knowledge
GVP/GLP knowledge or certifications a plus
BS in a scientific or other relevant discipline with equivalent work experience
Business and Operational acumen to include escalation to management
Ability to interact with all levels within a global organization
Experience in using eQMS systems, such as Veeva

Perform/manage SOP reviews or updates, contribute to the annual audit plan and provide input (including metrics) to prepare for Quality Management Reviews

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Ensure R&D clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards and best practices

Minimum 3-5 years of experience in a clinical operations role at a CRO or Sponsor, to include management of a study at a cross-functional level

This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.