Director Dps Scq Business and Lm Lead

vor 3 Wochen

Le Locle, Schweiz Johnson & Johnson Vollzeit

Our journey to transform the MD Supply Chain Quality operating model continues, as we work to enable our vision of leading the way for the customers and patients who count on us. The Supply Chain Quality Business Leader will ensure that we are better aligned to support the needs of the business, ultimately helping to transform the way we serve customers and patients with high-quality and compliant products each and every day into the future.

The Business and LM Lead is responsible for maintaining high quality product supply to our customers through strategies that drive continuous quality excellence, maintain supply chain compliance, providing platform support and addressing customer facing needs. In addition, this leader will identify and implement key capabilities, positioning Supply Chain Quality a competitive advantage by unlocking productivity and accelerating execution. Additionally, this role will be responsible for the management of the Quality Management System (QMS) of Medos International Sàrl Legal Manufacturing base business activities and manage audits/inspections from Health Authorities, Notified Bodies, J&J and customers.

**duties & responsibilities**:
Under limited supervision and in accordance with all applicable federal, state, and local laws, regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Serve as the single point of contact for the Medos International Sàrl Legal Manufacturing base business activities in all the End-to-End platforM/Franchise forums developing and driving End-to-End Supply Chain Quality strategies.
- Provide Quality inputs for DePuy Synthes LM project framing and execution
- Collaborate with DPS Quality leads and Supply Chain partners in identifying and deploying platform end to end strategies associated with Service, Quality, Cost, and People enabling platform Strategic, Financial and Long-Range Financial Planning
- Set the strategic direction for the DPS Mitek, Spine and TECA sites and External Suppliers in relation to the execution of process, equipment, and computer validation. Working with our engineering partners building SME capability across these sites to ensure standardized and efficient execution of these processes.
- Support or lead strategic projects on behalf of DePuy Synthes Supply Chain Quality
- Support the resolution of platform escalations associated with QMS, Compliance, Remediation & Audit Strategies
- Support network projects aligned to the Supply Chain Quality organization.

**Management Representative & PRRC for Medos International Sàrl**:

- Ensure that all processes needed to operate both the Medos International Sàrl Legal Manufacturing entities including implementation of EU MDR are established, implemented, and maintained. Quality oversight of any Medos International Sàrl entity programs being implemented for changing business needs. Acts as the Person Responsible for Regulatory Compliance (PRRC) for Medos International Sàrl (DePuy Mitek, DePuy Spine & Cerenovus) under the new EU MDR regulations
- Support the resolutions of platform escalations associated with QMS, Compliance, Remediation & Audit Strategies
- Detailed Management Representative and PRRC responsibilities are specified in a separate job description per 1006122422 in appendix 1. This document is stored in the PLM system.

**Additional responsibilities include**:

- Compliance:

- Ensure the Quality Management System (QMS) requirements are effectively established and maintained.
- Report QMS performances and communicate business related issues/opportunities to the next Management level. Promote awareness of regulatory requirements throughout the organization.
- Establish and maintain quality assurance programs, procedures, and controls. Ensures compliance with company policies and procedures.
- Review and approve Intra Company Quality agreements (ICQA) as well as Supplier Quality agreements. Ensure approved supplier list is kept up-to-date in One ASL
- Ensure that Medos International Sàrl products quality and performance conform to established company and regulatory standards. Guarantee adequate Quality & Compliance oversight of both internal and external subcontractors.
- Carry out leading responsibilities in accordance with the organization’s policies and applicable laws including health and safety.
- Provide feedback on problems related to quality and/or compliance. Initiate/support investigations.
- Initiate and maintains interplant communications of quality issues.
- Supports Internal audit programs. Reviews reports findings
- Host external audits/inspections and be the main point of contact for External auditors and inspectors.
- Projects:

- Lead DePuy Synthes strategic projects (End-to-end Quality).
- Guarantee oversight of New Product Introduction (NPI) as well as product transfers/obsolescence.
- Ensures that the quality aspects for new processes, products and or upgrading of existing processes and products and subsequen

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