Manager, GCP Quality Assurance

2 months ago

Conshohocken, United States Madrigal Pharmaceuticals Inc 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.Position Responsibilities: Ensure clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standardsAlign organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrityApply a risk-based approach by working collaboratively cross-functionally to ensure complianceAttend routine internal, external study team and ad hoc calls in support of ongoing quality oversightEngage partnership with external vendors via adherence to Quality Agreements and routine meetingsCoordinate reviews, management documentation, track and/or follow-up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closureSupport the use of an eQMS via data entry/document upload of quality activities (audits, observations, inspections, CAPAs, SOP Deviations, QEs/Investigations) and SOP updatesContribute to the annual audit planAssure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelinesMay review vendor MSA or contract/Work OrdersConduct or manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reportsCoordinate and manage services provided by external QA vendorsReview key documents, such as IB, Protocols/Amendments, Consents, TMF PlansInform and escalate to management in real-time or during routine updates, as appropriateParticipate in inspection readiness activities or provide support during global agency inspectionsConduct 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 practicesQualifications and Skills:Overall qualification by experience to support the responsibilities not limited to those outlined aboveDemonstrated GCP knowledge, GLP/GVP knowledge a plusSolid 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 relationshipsBusiness and Operational acumen to include escalation to managementAbility to interact with all levels within an organizationExperience in inspection preparation or supporting regulatory agency inspectionsExperience in using eQMS systems, such as VeevaBS in a scientific or other relevant discipline with equivalent work experienceMadrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.

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