Auditor II, Global GMP/GDP Audits

California, US residents.

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 develop treatments for rare, deadly diseases. Founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH), 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 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. We are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, aiming to eliminate the transplant waiting list and cure end‑stage organ diseases not currently designated for transplant.

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. The role also involves assisting with the implementation of Quality Agreements, providing support during regulatory inspections, and participating in assigned quality improvement initiatives. Additionally, the auditor communicates with other UT departments regarding vendor change notifications and/or quality events to ensure processes, materials, and services continue to comply with UT and regulatory standards.

Responsibilities

• Conduct initial and routine audits of quality management system elements including but not limited to manufacturing, packaging, 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 ongoing 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.<