Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)

About the role

The Auditor II plays a crucial role in ensuring that appropriate quality systems are in place at United Therapeutics (UT) sites and at approved GMP/GDP suppliers/service providers. They conduct internal audits, qualification audits, and surveillance audits to verify compliance with UT and regulatory standards.

Responsibilities

• Conduct initial and routine audits of quality management system elements including 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 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.
• Include 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.
• Cook up and 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.
• 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.
• Aid in the development and review of initial Agreements with GMP/GDP suppliers/service providers when required.

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.
• 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 the ability to obtain a passport.
• Strong attention to detail and commitment to seeing tasks through to completion.
• Proven organizational skills and strong ability to prioritize workload.
• Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, including upper management.
• Experience and comfort in working both independently and as part of a multifunctional team.
• Experience auditing sterile manufacturing, solid dose manufacturing, and biologic manufacturing operations.
• Experience reviewing medical device development documents and Design History Files.
• Commitment and ability to handle changing priorities, stressful situations, and deadlines.
• Working knowledge of electronic QMS systems such as SAP, Trackwise Digital, and MasterControl.

Preferred Requirements

• Master’s Degree degree in a science or engineering related field or Doctor of Philosophy (PhD) degree in a science or engineering related field.
• Certified Quality Auditor ASQ or ISO lead auditor certification is desirable.
• RAPS Regulatory Affairs Certifications (RAC) is desirable.
• Experience auditing sterile manufacturing, solid dose manufacturing, and biologic manufacturing operations.
• Experience reviewing medical device development documents and Design History Files.
• Commitment and ability to handle changing priorities, stressful situations, and deadlines.
• Working knowledge of electronic QMS systems such as SAP, Trackwise Digital, and MasterControl.

Pay

$88,000 - $135,000 per year

Schedule

This position requires up to 50% travel to manage cGMP activities and conduct site and vendor compliance audits. Some international travel required. Must be able to travel independently and without restriction.

Benefits

United Therapeutics offers a comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit here.

Equal Opportunity Employer

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.