Auditor II, Global GMP​/GDP Audits & Compliance; local to RTP or Silver

Position: Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)
California, US residents  () .

** The job details are as follows:*
* Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

The Auditor II is responsible for ensuring that appropriate quality systems are in place at UT sites and at approved GMP/GDP suppliers/service providers through internal auditing, qualification (auditing) and surveillance (auditing) of GMP/GDP vendors, assisting with implementation of Quality Agreements, providing support during regulatory inspections, and participating in assigned quality improvement initiatives. The role will also be responsible for communicating with other UT departments regarding vendor change notifications and/or quality events to ensure vendor manufacturing processes, vendor materials, and services continue to comply with UT and regulatory standards.

+ Conduct initial and routine audits of quality management system elements including but not limited to manufacturing and packaging processes, facilities, distribution practices, analytical processes, technical reports and design history files. Perform mock pre-approval inspections as needed.

+ Follow good auditing practices by assisting with the development of a risk-based audit schedule, creating clear and focused audit plans, preparing detailed audit reports with well-supported findings, evaluating audit responses and corrective action plans, following up on outstanding quality issues and tracking on-going compliance with cGMPs

+ Conduct internal audits of UT facilities and processes from the development stage through commercialization

+ Conduct assessments and audits of current and potential GMP/GDP CMOs and vendors to assure compliance with UT standards and current GMP and/or GDP regulations

+ Prepare vendor risk assessments and, where applicable, risk control plans to ensure ongoing regulatory compliance and maintenance of product and process quality. Includes review of internal and external data (e.g. supplier quality events and change notifications) to compile product and vendor quality history

+ Contribute to the management and oversight of the GxP Vendor List through review and approval of new material part numbers and new vendor requests

+ Deal effectively and diplomatically with CMOs, suppliers, service providers, and other UT departments. Coordinate audit activities with other team members. Participate in the investigation of quality issues related to product failures, contractor complaints, customer complaints as needed or as directed by QA Management.

+ Support UT development projects and facilities to ensure full cGMP compliance at product launch. Duties include participation in development teams, training UT personnel on vendor management procedures and prioritizing new vendor qualifications

+ Receive, assess and when appropriate disseminate Vendor Change Notifications to qualified UT personnel

+ Monitor and prepare reports on quality management system performance including vendor performance and internal quality system goals

+ Review and evaluate UT procedures and policies to assure consistency with pertinent government regulations and guidelines

+ Assist in the development and review of initial Agreements with GMP/GDP suppliers/service providers when required

Minimum Requirements

+ Bachelor's Degree in a science or engineering related field

+ 5+ years of experience auditing and/or managing suppliers in an FDA medical device/pharmaceutical regulated industry is required

+ Strong working knowledge of cGMP pharmaceutical and medical device regulations and guidelines, both US (21 CFR Parts 4, 11, 210 211 and QMSR) and familiarity with appropriate ISO and ICH standards.

+ Must have a valid passport or…