Senior Global Quality Compliance Auditor

February 21

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

🦞 Maine – Remote

Although this job is listed in Maine, this company may be open to hiring remote in other states.

+2 more states

🐊 Florida – Remote 🦞 Maine – Remote 🗻 New Hampshire – Remote 🌲 Oregon – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

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Uwi (AI Recruiter by HeroHunt.ai)

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Uwi (AI Recruiter by HeroHunt. ai) is an innovative recruitment platform that automates the full cycle of talent acquisition. It is powered by advanced AI technologies such as RecruitGPT, which enables it to conduct AI-driven candidate searches and screenings. Uwi can autonomously reach out to potential candidates and personalize outreach using prompt-based AI. Its platform integrates with various data sources to find candidates globally, offering services such as LinkedIn profile searches and outreach automation to provide efficient recruitment solutions with minimal effort from users. This service aims to reduce the time and costs associated with hiring by leveraging AI's capabilities to find the best talent worldwide.

Scaleup • Talent • Sourcing • Recruitment • Startups

11 - 50 employees

👥 HR Tech

🤖 Artificial Intelligence

☁️ SaaS

📋 Description

• Perform Supplier Quality assessments/audits of critical Suppliers and Contractors to the annual plan and follow up on agreed upon CAPAs. • Assess Suppliers' quality and ability to meet requirements using tools like Quality Risk Management (QRM), supplier assessment/audit, organizational change, and complaint/deviation trend management. • Act as Single Point of Contact (SPOC) for assigned suppliers from a global portfolio, representing the Head of Global Quality Compliance US. • Plan and complete corporate GMP compliance audits/assessments for medium and low risk manufacturing sites and operations as a Co-auditor. • Advise and support sites in devising and completing remediation actions to ensure compliance with regulatory and Lonza expectations. • Provide expertise on GMP compliance and standard methodologies to sites and the global organization. • Develop and maintain audit plans based on risk assessment principles, complete supplier audits/assessments, produce detailed reports, and communicate deficiencies and compliance risks. • Contribute to the reporting on QA Supplier performance, including ranking the Risk Assessment and handling critical metrics.

🎯 Requirements

• Bachelor’s degree or equivalent experience required; Master’s of Science preferred. • 5-10 years of validated experience in a similar role within the pharmaceutical or biotechnology industries. • Expertise in Quality Risk Management, supplier assessment/audit, and compliance risk analysis. • Strong proficiency in regulatory guidelines and quality management systems. • Outstanding attention to detail and ability to work closely within regulatory guidelines. • Proven track record to determine and successfully implement quality and compliance improvements. • Strong collaborative skills, with a dedication to contributing to an inclusive and world-class team environment.