Now Hiring - Resilience (CA) - Senior Specialist II, SAP QM in West Chester, OH

General Company Description

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives. For more information, visit

• Technical and functional understanding of SAP QM (Quality Management) and Global Batch Traceability business process and system architecture
• Experience in SAP QM end-to-end configuration worked in the following area:
  • Change Requests
  • QM Master data
  • Quality Planning
  • Quality Inspection (Incoming, In-process, Final)
  • Quality Notifications

• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Identify gaps, quality issues and work around solutions in SAP
• Interfaces with applicable site support groups on projects (capital and non-capital) that impact the assigned area, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects
• Collaborates with, and influences, other assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
• Map client business requirements, processes, and objectives; develops necessary product modifications to satisfy clients' needs
• Train and transfer knowledge to other team members, users and stakeholders as required
• Experience working on integration with 3rd party systems using Outbound and Inbound EDI messages, IDOCs error handling

• Experience in Global Batch Traceability business process and system architecture
• Influence team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
• Experience working with SAP PI/PO resources in integrating SAP with 3rd Party systems.
• Help drive standardization on the use of ERP systems across the organization
• Act as a key customer representative and subject matter expert for SAP QM and business processes, attending and leading meetings when required
• Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Client Values, FDA & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

• 10 years of experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
• Bachelor’s degree or Master’s degree in Quality Assurance /Regulatory Affairs or related field
• Expert knowledge in QM - both functional and technical in areas like Quality Inspections, Notifications, Batch Management, Equipment calibration, Physical samples, Multiple specifications, Stability analysis, CofA, and Workflow management, apart from all basic QM functionalities in SAP with respect to QM in production, procurement, and sales
• Experience in SAP ECC QM Integration points with MM, PP, SD, WM, and PM

• 5 years of experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
• Expert knowledge in QM - both functional and technical in areas like Quality Inspections, Notifications, Batch Management, Equipment, and Quality Systems
• Individual contributor with a strong ability and motivation to learn
• Knowledge of FDA and regulatory requirements in the quality management area
• Must have knowledge of business processes for end-to-end solutions for quality control, inspection operations, and lot disposition functions
• Ability to coach and mentor peers in leading SAP or quality projects

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $90,000.00 - $115,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.