PURPOSE AND SCOPE:
The E2E Regulatory Affairs (RA) & Quality Management (QM) Process Expert & Transformation Lead is accountable for driving global standardization, operational excellence, and transformation across the end-to-end (E2E) RA & QM value chain.
RA & QM functionality sits overall within the SQR (Systems, Quality & Regulatory) business function.
This role provides deep functional and process expertise and serves as the primary regional/global or functional authority supporting the Global Process Owner (GPO). The incumbent ensures global process standards are effectively deployed and adhered to locally, while leading high-priority, cross-functional simplification and transformation initiatives.
The main RA & QM processes & activities are:
- RA: Product Regulatory Affairs
- RA: Drug Operations
- RA: Drug Strategy (US / EU / non-EU)
- RA: Drug Labelling
- RA: Distributor Management
- QM: Clinical Evaluation Reports
- QM: Documentation Control
- QM: Learning & Training
- QM: Supplier Quality
The role focuses on:
- Achieving convergence toward a unified E2E process taxonomy
- Designing and governing a harmonized service delivery model
- Governance of global process documentation
- Establishing and monitoring standardized KPIs
- Leading enterprise-wide transformation programs
- Shaping a stakeholder-aligned future-state operating model
The position acts as a critical link between strategy, operations, and system enablement (e.g., ERP/SAP S/4HANA).
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Lead the design, harmonization, and implementation of E2E RA & QM processes, including interdepartmental handoffs and global sub-process definitions.
- Provide deep process expertise in day-to-day process execution, systems, workflows, and exception management.
- Drive global standardization and ensure consistent deployment of the unified E2E process taxonomy, service delivery model, and KPI framework.
- Identify process bottlenecks, performance gaps, and risks impacting KPIs, and implement corrective actions.
- Collaborate closely with the Global Process Owner (GPO) and cross-functional stakeholders to define future-state processes, roadmaps, and transformation priorities.
- Lead high-priority, cross-functional transformation and simplification initiatives aligned with enterprise strategy.
- Act as the single point of contact for Demand Management related to RA & QM and manage the change intake funnel.
- Maintain and govern global process documentation, ensuring compliance with global standards, policies, and control requirements.
- Monitor, analyze, and report process performance metrics, driving continuous improvement and optimization initiatives.
- Serve as the primary point of contact for benchmarking, industry best practices, and innovation with RA &QM.
- Support SAP S/4HANA and other ERP implementations by translating business requirements into standardized, optimized process solutions.
- Ensure system configurations align with global process standards and target operating model.
- Oversee process transformation execution to ensure delivery within scope, timeline, budget, and strategic objectives.
- Facilitate workshops and working sessions with global stakeholders to ensure alignment, engagement, and adoption of process changes.
- Ensure global and local process execution complies with regulatory requirements, internal policies, and control frameworks.
- Govern and manage local deviations in accordance with legal, audit, and compliance standards.
- Provide input and documentation support for audit and compliance reviews when required.
- Mentor process analysts and provide guidance to operational teams to strengthen capability and drive operational excellence.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- Preferably located in a GBS Hub
- Willingness to travel occasionally (20%)
SUPERVISION:
Reports to GPO / Head of GBS Process Management
EDUCATION AND REQUIRED CREDENTIALS:
- Bachelor’s degree in Business Administration, Engineering, Healthcare, Life Sciences or related field.
- Advanced degree preferred.
- Lean Six Sigma Green/Black Belt certification is a plus.
- Project Management certification (PMP, PRINCE2) is an advantage.
EXPERIENCE AND SKILLS:
- Ability to structure, prioritize and critical design thinking.
- Proven leadership of cross-functional transformation or process improvement initiatives.
- Exceptional stakeholder management and influencing skills, with the ability to drive consensus across diverse teams.
- Strong analytical and problem-solving skills, with the ability to balance strategic thinking with operational execution.
- Excellent communication, presentation, and workshop facilitation skills.
- Demonstrated ability to lead complex stream in a global, matrixed organization.
- Experience in shared services or Global Business Services (GBS) organizations preferred.
- Strong knowledge of ERP systems (e.g., SAP S/4HANA, Oracle) with hands-on implementation experience.
- Preferred experience with Windchill Product Lifecycle Management (PLM) tool and / or document control systems
- Experience with process design methodologies (BPMN, Lean, Six Sigma).
- Budget creation and management responsibility.
- Strong change management and facilitation capabilities.
- English Advanced, other languages an advantage
ACKNOWLEDGEMENT:
I acknowledge that I have read and accepted this job description. I understand what is expected of me in this position, and I am able to perform the essential functions as outlined with or without reasonable accommodation. Furthermore, I understand that the duties and responsibilities listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. If I have any questions about duties and responsibilities not specified in this job description that I am asked to perform, I should discuss them with my immediate supervisor or my Human Resources representative.
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Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.