Job Description
Role: Quality ERP Global Batch Traceability
Location: Collegeville, PA 19426 (Can work remotely.)
Duration: 12 months
Shift: First Shift - day shift
Note: Must have SAP experience and Pharmaceutical industry experience.
Job Purpose:
Key Responsibilities:
Basic Qualifications
Preferred Qualifications
Education: Bachelor s Degree or higher in Science, Business, Math, or Engineering
Location: Collegeville, PA 19426 (Can work remotely.)
Duration: 12 months
Shift: First Shift - day shift
Note: Must have SAP experience and Pharmaceutical industry experience.
Job Purpose:
- The Quality ERP Global Batch Traceability will focus on quality business processes on behalf of Global Supply Chain to support the ERP Transformation program across the Medicines and Vaccines businesses. Ensure robust GxP compliance oversight and audit readiness processes are embedded within the design, delivery, and lifecycle support.
- Reports to the ERP Quality Cluster Lead, the role involves collaboration with Quality Cluster team members, functional leads, BI/SI partners, and business units to ensure successful implementation of target state processes. The role spans all GSC geographic locations and operates in a highly matrixed team.
Key Responsibilities:
- Deliver business requirements for GSC Quality and collaborate with functional teams to ensure proper template design and resolve issues specifically to support the new Global Batch Traceability system.
- Define business scenarios for testing activities, ensuring alignment across the Medicines and Vaccines businesses.
- Resolve compliance and quality issues by escalating through appropriate governance forums in collaboration with the ERP Quality Cluster Lead.
- Manage stakeholder engagement across GSC locations during program phases for smooth transitions to new processes.
- Ensure end-to-end alignment with ERP program and systems supporting the process (e.G., SAP S4, Batch Release Hub, etc.).
- Collaborate with sites across the GSC network to ensure adherence to global processes and minimize local variations.
- Deliver global business process documentation for GSOPs and related materials in line with program standards.
- Support development and implementation of training materials and deployment methodologies.
- Identify and resolve risks, issues, and interdependencies to ensure program success.
- Identify and resolve risks, issues, and interdependencies to ensure program success.
Basic Qualifications
- Bachelor s Degree or higher in Science, Business, Math, or Engineering
- 10+ years experience in pharmaceutical quality systems.
- SAP Quality Experience on 2-3 full project lifecycle implementations
- Interpersonal skills in business and technical environments.
- Effective influencing and people skills to drive consensus across diverse teams.
- Strong stakeholder engagement skills in matrixed environments.
- Strong collaboration skills in a matrix environment
- Business Requirements gathering experience
- Experience with the following pharmaceutical business processes: Quality investigations, Product Recall, Product Withdrawal, Product Complaints, Regulatory analysis of batch genealogy, Product safety, Quality Release, and Product Returns.
Preferred Qualifications
- Experience managing global supply chain networks and operations.
- Knowledge of ERP systems and related processes (e.G., SAP ECC, SAP S4, SAP Global Batch Traceability, SAP Batch Release Hub, LES (Lab system), eQMS, etc.).
- Experience using SAP Global Batch Traceability in Vaccines or Medicines business
- Experience with SAP Batch Genealogy in Pharmaceutical industry
- Experience with SAP Batch Release in Pharmaceutical industry
- Knowledge of Vaccines or Medicines Business Processes to provide business requirements related to Global Batch Traceability
Education: Bachelor s Degree or higher in Science, Business, Math, or Engineering
Numbers & Facts
| Location | Collegeville, PA |
| Industry | Staffing/Employment Agencies |
| Salary | $90 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Business Intelligenceunmatched
- Business Processesunmatched
- Business Skillsunmatched
- Documentationunmatched
- ERP (Enterprise Resource Planning)unmatched
- Embedded Systemsunmatched
- GxPunmatched
- International Businessunmatched
- Interpersonal Skillsunmatched
- Laboratory Systemsunmatched
- Maintain Complianceunmatched
- Mathematicsunmatched
- Medical Productsunmatched
- Problem Solving Skillsunmatched
- Product Safetyunmatched
- Project Lifecycleunmatched
- Regulationsunmatched
- Requirements Managementunmatched
- Risk Analysisunmatched
- SAPunmatched
- SAP ECC (fka SAP R/3 and SAP ERP)unmatched
- Supply Chainunmatched
- Supply Chain Managementunmatched
- Supply Chain Operationsunmatched
- System Integration (SI)unmatched
- Systems Administration/Managementunmatched
- Team Playerunmatched
- Test Scenariounmatched
- Traceabilityunmatched
- Vaccinationunmatched
- Work From Homeunmatched
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