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.