Elena Krüger

Company profile: Consumer Care

• Deputy Person Responsible for Regulatory Compliance
• Support the maintenance and continuous improvement of the Quality Management System based on current ISO / MDR requirements / country legislation
• Involved in operating model definition for topics as: E2E Supplier Qualification & Medical Devices
• Own the relation with the Notified Body, including audit activities, budget, maintenance and renewal of CE certificates for products where Bayer acts as Legal Manufacturer
• Support product launches and new product developments, and provide guidance and expertise during due diligence, mergers & acquisitions, and in-licensing projects
• Evaluate, qualify, and monitor suppliers (contract manufacturers / service providers) and manage related supplier performance processes
• Lead Clinical Audit preparation while partnering with: Quality, Regulatory, Medical Affairs and Pharmacovigilance functions
• One direct report

Key Achievements

• Lead a cross functional team responsible to sustain annual Surveillance Audits with designated Notified Body with a successful outcome on maintaining existing certificates

Company Profile: Medical Devices

• Lead a project team with the scope to reach Medical Device Regulation (MDR) compliance within defined program timelines for allocated areas in the organization
• Partnering with different Workstream leaders, business stakeholders and management to ensure process/procedures, organizational changes and system updates have been modified to address the new EU regulatory requirements
• Providing supervision and guideline for contractors supporting from technical side the ongoing activities

Key Achievements:

• Deliver for five major areas the strategy, process design and implementation support to achieve regulatory compliance before date of application

Company Profile: Consumer Care

• Lead the work stream for Economical Operators in regards of MDR implementation for Medical Devices and Combination products in Consumer Sector (for EMEA region)
• Close collaboration with Compliance Vigilance, local Quality Heads affiliates, Regulatory Affairs, Procurement, Operations, Legal and Technical teams
• In charge of nine External Manufacturers with a total NTS of 130 mil USD covering: Medicinal Products, Combination Products and Medical Devices
• Manage quality issues: review of deviations, out of specifications, non-conformances and other critical issues; investigation review, follow up on resulting action plans, CAPAs and J&J audits
• involved in validation review for product transfer or product/process changes
• Lead Quality Agreements negotiations
• Ensure continuous improvement process of External Manufacturers through KPI monitoring, Gemba walks, J&J lean initiatives, on site Quality reviews, etc
• Support HA (health authorities) and Notify Body inspections (including MDSAP: Medical Device Single Audit Program)
• Manage the assigned EM portfolio against EU, FDA and ISO regulations and as well across regions (EMEA, APAC and NA)
• One direct report: contractor (one-year contract)

Key achievements:

• Redesign and implement a standardized process to exit External Manufacturers, while involving all impacted stakeholders
• Supporting multiple divestitures while ensuring that all GMP activities are correctly completed during the transition and as well after the exit phase.
• supervising and mentorship of 2 new colleagues in the team
• build the data base for Medicinal Products containing a Medical Device component.

Company Profile: medical devices

• Performing technical assessments at preferred suppliers
• Ensure effective and timely closure of Supplier Corrective Action Requests
• Implement and perform periodic reviews of Quality Agreements, Business reviews and KPIs
• Review and approve Validation of new/changed supplier production process
• Four indirect reports

Key Achievements:

• 12 months KPI for supplier's non-conformities on green area

• Company Profile: Retail
• Definition of product characteristics and legal coverage for common source own brand non-food products delivered in 25 countries
• Direct coordination for: household, office, indoor & outdoor furniture with a portfolio of 120m€
• Developing and maintaining business relation with external providers: with following tasks: Definition of applicable tests, cost negotiations, samples definition, outgoing inspections, audits, workshops, etc
• Coordination together with Buying Teams of projects sourced from Asia - via Honk Kong / Shanghai / Vietnam office and Europe
• Leading cross functional Quality Assurance teams at project level (1 - 4 members)

Key Achievements:

• Innovative approach by running first six sigma project in the company
• 500 articles launched per year successfully covering legal and customer demands

• Company Overview: automotive / die casting
• In charge for two customers representing 8m€ of total business turnover
• Answering to the customer in real time for complains and develops the strategy to solve the issues by using 5 Why analyses and Fish Bones Diagram
• Leading the plant presentation/verification during customer audits in the house
• Direct supervision of QC team (4 members)

Key Achievements:

• Leading a team with a target to increase customer score card with the result of a lift from "C" to "B" cluster

Company Profile: Electronics

Company Profile: Automotive / seat belts

• Part of the team responsible for transferring one product family of seat belts from Autoliv Nord Germany to Autoliv Romania: resources allocation, training of people, laboratory tests, samples and PPAP approval, run & rate, audits

Key Achievements:

• Supervising and mentorship of approx. 10 people (by providing training for: Quality Assurance tools, suppliers, PPAP, automotive industry requirements for the first 3 months in the company)
• Six months working in Autoliv Nord Germany on SQA position for a new project for Daimler Chrysler