Quality ERP Global Batch Traceability Specialist
$92 - $97 per hourAlphanumeric Systems Inc.
Job Description
Job Description
Quality ERP Global Batch Traceability Specialist
Collegeville, PA (Onsite/Hybrid)
Alphanumeric (Supporting a Global Pharmaceutical Leader)
Pay Rate: $92 - $97/hour (W2)
Shift: Day Shift
Alphanumeric is hiring a Quality ERP Global Batch Traceability Specialist to support our long-standing global pharmaceutical client committed to improving lives through medical and vaccine innovation.
This role sits within a global ERP transformation program and focuses on quality business processes across Global Supply Chain (GSC) , ensuring GxP compliance, audit readiness, and standardized batch traceability processes across Medicines and Vaccines businesses worldwide.
You will partner with cross-functional stakeholders in a highly matrixed global environment to design, implement, and sustain future-state ERP solutions.
What You'll Do:
- Lead quality business requirements for Global Supply Chain, supporting the Global Batch Traceability solution.
- Collaborate with functional teams to ensure accurate ERP template design and issue resolution.
- Define and support UAT testing scenarios aligned across Medicines and Vaccines.
- Ensure GxP compliance and audit readiness across design, deployment, and lifecycle.
- Partner with ERP Quality Cluster Lead and governance teams to escalate and resolve quality/compliance risks.
- Drive stakeholder engagement across global GSC sites to support adoption and transition.
- Ensure alignment with key systems including SAP S/4HANA, Batch Release Hub, and related platforms.
- Standardize processes globally while minimizing local variation.
- Develop and maintain GSOPs and global process documentation.
- Support training development and deployment strategies.
- Identify and manage risks, issues, and interdependencies across the program.
Basic Qualifications:
- Bachelor's degree (Science, Engineering, Business, or related field).
- 10+ years of pharmaceutical quality systems experience.
- SAP Quality experience across 2-3 full lifecycle implementations.
- Strong experience in business requirements gathering.
- Deep understanding of pharmaceutical processes:
- Quality Investigations.
- Product Recall & Withdrawal.
- Product Complaints.
- Batch Genealogy & Regulatory Analysis.
- Product Safety.
- Quality Release.
- Product Returns.
- Proven ability to influence and drive alignment across technical and business teams.
- Strong collaboration and stakeholder management skills in matrixed global environments.
Preferred Qualifications:
- Experience supporting global supply chain operations.
- Hands-on experience with:
- SAP ECC / SAP S/4HANA.
- SAP Global Batch Traceability.
- SAP Batch Release Hub.
- Lab systems (LES) / eQMS.
- Experience with:
- SAP Batch Genealogy.
- SAP Batch Release (Pharma).
- Background supporting Vaccines or Medicines business processes.
- Why Join This Program?
- High-visibility role in a global ERP transformation.
- Direct impact on patient safety and product quality.
- Opportunity to work across global supply chain and quality organizations.
- Long-term engagement with a top-tier pharmaceutical leader.
Vacancy posted 12 days ago
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