Job Title: Quality Management (QM) Consultant SAP QM | Pharmaceutical

Job Title: Quality Management (QM) Consultant SAP QM | Pharmaceutical

Location: Princeton, NJ (Day 1 Onsite)
Duration: Contract
Employment Type: W2

Job Description

We are seeking an experienced Quality Management (QM) Consultant with a strong background in SAP QM and pharmaceutical quality operations. The ideal candidate will act as a business-facing consultant, partnering with Quality Assurance (QA) and Quality Control (QC) teams to support quality processes, regulatory compliance, and SAP S/4HANA initiatives within a GMP-regulated environment.

Key Responsibilities

• Serve as the primary business-facing Quality Management (QM) Consultant, supporting Quality Assurance (QA) and Quality Control (QC) operations within a pharmaceutical manufacturing environment.
• Collaborate with cross-functional Quality teams across the U.S. and India to support quality processes and drive continuous improvements.
• Manage and support quality operations, including:
  • Batch Record Management
  • Sampling Management
  • Inspection Lot Management
  • Quality Notifications
  • Quality Compliance
  • Deviations, CAPA, and Change Control processes
• Support quality activities involving Third-Party Logistics (3PL) providers while ensuring compliance with regulatory and business requirements.
• Participate in SAP S/4HANA implementation projects with a focus on User Acceptance Testing (UAT), validation, testing, and business process optimization.
• Work with integrated laboratory and quality systems, including:
  • Laboratory Information Management Systems (LIMS)
  • Electronic Logbooks (eLog)
  • Electronic Laboratory Notebooks (eNotebook/ELN)
• Ensure adherence to GMP, GxP, FDA, and 21 CFR Part 11 compliance standards.
• Partner with business stakeholders to identify process improvements and optimize SAP QM functionality.
• Provide subject matter expertise on pharmaceutical quality processes, industry regulations, and SAP QM best practices.
• Support issue resolution, documentation, training, and knowledge transfer activities.

Required Qualifications

• 5+ years of experience in SAP Quality Management (SAP QM).
• Strong experience supporting Quality Assurance (QA) and Quality Control (QC) processes.
• Experience working within the pharmaceutical, biotechnology, or life sciences industry.
• Hands-on experience with:
  • Batch Record Management
  • Inspection Management
  • Quality Notifications
  • Sampling Processes
  • Quality Compliance
• Experience supporting SAP S/4HANA implementation or migration projects.
• Strong experience with User Acceptance Testing (UAT).
• Experience working with LIMS, Electronic Logbooks (eLog), and Electronic Laboratory Notebooks (ELN/eNotebook).
• Strong understanding of GMP, GxP, FDA regulations, and 21 CFR Part 11.
• Experience supporting 3PL quality operations is highly preferred.
• Excellent communication and stakeholder management skills.

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