GCP, Quality Assurance Candidate

Conshohocken, PA
Quality Assurance /
Full Time /
This position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to 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.


Ensure clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards

Align organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrity

Apply a risk-based approach by working collaboratively cross-functionally to ensure compliance

Attend routine internal, external study team and ad hoc calls in support of ongoing quality oversight
Engage partnership with external vendors via adherence to Quality Agreements and routine meetings

Coordinate reviews, management documentation, track and/or follow-up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closure

Support the use of an eQMS via data entry/document upload of quality activities (audits, observations, inspections, CAPAs, SOP Deviations, QEs/Investigations) and SOP updates

Contribute to the annual audit plan

Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines

May review vendor MSA or contract/Work Orders

Conduct or manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reports

Coordinate and manage services provided by external QA vendors

Review key documents, such as IB, Protocols/Amendments, Consents, TMF Plans

Inform and escalate to management in real-time or during routine updates, as appropriate

Participate in inspection readiness activities or provide support during global agency inspections

Conduct other tasks in support of GCP Quality activities, (e.g., chase training assignments, request contracts)

Stay abreast of applicable global regulations, guidances, and industry best practices

Overall qualification by experience to support the responsibilities not limited to those outlined above
Demonstrated GCP knowledge, GLP/GVP knowledge a plus
Solid understanding of the cross-functional drug development process including specific to clinical trial operations, data management, statistics, etc
Skilled in developing collaborative internal and external relationships
Business and Operational acumen to include escalation to management
Ability to interact with all levels within an organization
Experience in inspection preparation or supporting regulatory agency inspections
Experience in using eQMS systems, such as Veeva
BS in a scientific or other relevant discipline with equivalent work experience