Director DPS SCQ Business and LM Lead

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 subsequent validations are met.
• Acts as advisor to subordinate Managers, supervisors or staff to help meet established schedules or resolve technical or operational problems.
• Formulates and maintains quality control objectives and coordinates objectives with Design & Manufacturing Centers in cooperation Plant Quality Managers to maximize product reliability and minimize costs.
• Provide input to design direction or product line modifications and adequacy of design and test results.
• Provides quality control support to the supplier quality assurance as requested or needed.
• Continuous Improvement:
• Ensures oversight of engineers in development and deployment of innovative quality engineering tools, techniques and systems that will drive product development to successfully achieve key business.
• Promotes the use of Process Excellence tools to enhance analytical thinking and problem-solving techniques.
• Supports on-going continuing efforts and projects to improve the overall Quality Management System (QMS)
• Ensures the Implementation of world-class quality engineering systems.
• Leadership/People Management:
• Effectively integrate and utilize Quality Assurance, Quality Systems, Quality Engineering and Compliance in support of Global Supply Chain, Quality Objectives and Compliance policies.
• Direct and administer the activities of Managers, Supervisors, Quality Engineers and dotted Supplier Quality Engineers and associated administrators.
• Perform Annual Performance appraisals for the identified associates. Establish objectives and development plans for direct reports or applicable processes. Recommends salary increases for direct subordinates.
• Responsible to hire and develop talents within the Quality Make Organization.
• Develop the department skills in compliance, new technologies, lean and other as required.
• Evaluate and recommends staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
• Fosters teamwork and supports total associate involvement.
• Actively supports other plant functions in the implementation of company programs and projects.

Finance:

• Develop a financial budget to support Quality, supply reliabilities and Compliance Objectives
• Submit and administer budget schedules and performance standards.
• Forecasts and manage headcount, capital, and other resource needed
• Approves purchases and expense reports submitted by direct reports.
• Supports and promotes cost savings opportunities that work toward global objectives in the organization.
• Environmental, Health, Safety & Sustainability (EHS&S):
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all equipment and resources needed to do their job are available and in good condition, if applicable.
• Participate and support safety initiatives, such as emergency response, ergonomics, safe behavior program, etc.
• Enforce, promote and observe all safety, industrial hygiene rules and regulations established by the Company.
• Report accidents, incidents, near misses, and hazardous situations in a timely manner and participate in the corrective action process.
• Other:
• Perform other duties assigned as needed.

Qualifications

Experience and Education

• Bachelor’s degree in a Life Science, Engineering, Physical Science or equivalent is required.
• Five (5) years of active management experience including direct supervision and matrix management is required.
• Ten (10) years related experience and/or training; or an equivalent combination of education and experience in a regulated environment is required.
• Strong communication, influencing and leadership skills. Ability to communicate at all levels of the organization, project management and problem solving are required.
• Knowledge of ISO and QSR/EU MDD-MDR regulations is preferred.
• Key front-room role experience with FDA (or similar) inspection and Notified Body inspections is preferred.
• Experience in the Medical Device industry or medical field is preferred
• Demonstrated knowledge of manufacturing principles and practices is preferred.
• Knowledge of specific business practices and software and software applications is preferred.
• Ability to work cooperatively with coworkers and the public is preferred.
• Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements.

REQUIRED KNOWLEDGE, COMPETENCES, SKILLS, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Strong communication, influencing and leadership skills: ability to communicate at all levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results is required
• Strong business acumen, interpersonal skills relating to teams with diverse cultures and business practices is required.
• Strong verbal and written communications skills for multi-level stakeholders
• Strategic and tactical execution abilities, including strong organization skills is required.
• Ability to take initiative regarding innovative approaches to problem solving in a fast paced, changing business environment is required.
• Ability to apply principles of logical or scientific thinking, root cause and statistical analysis.
• Ability to analyze, graph, and present data in a way that facilitates and drives decision making.
• Strong verbal and written Presentation Skills
• Effective people management and talent development skills to maximize collaboration with both direct and undirect reports.