Sr SQ Mgr Proactive Supplier Development

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• →Communicate business-related issues, risks, and opportunities to the appropriate management level.
• →Ensure personal compliance with all applicable company policies, procedures, and environmental, health, and safety requirements.
• →Exercise independent judgment within established policies and elevate matters that may affect patient safety, product quality, regulatory compliance, or continuity of supply.
• →Perform other responsibilities assigned based on business needs.

• Develop and maintain the Depuy Synthes supplier development and performance management strategy, governance model, standard work, tools, and deployment roadmap.
• Establish risk-based criteria for supplier segmentation, capability assessment, development prioritization, and intervention.
• Translate business, quality, compliance, product, and supply risks into targeted supplier development plans.
• Lead deployment of proactive supplier development methods, including technical assessments, process maturity reviews, robust process evaluations, capability improvement, quality culture development, and supplier training.
• Create scalable playbooks, templates, training materials, and best practices that enable consistent execution across business units, regions, and supplier categories.
• Serve as the subject matter expert for supplier development, supplier performance management, and proactive supplier quality improvement.

• Define and maintain supplier development & performance measures, scorecards, dashboards, governance routines, and escalation criteria.
• Analyze supplier data to identify adverse trends, systemic risks, recurring failure modes, and opportunities for early intervention.
• Facilitate periodic supplier performance reviews with Quality, Procurement, Supply Chain, Operations, and other stakeholders.
• Provide clear, fact-based recommendations regarding supplier development, escalation, recovery, sourcing, or risk-mitigation actions.
• Establish effectiveness measures to confirm that supplier improvement actions deliver sustained results.
• Present supplier performance trends, risks, decisions, and improvement progress to senior leadership and governance forums.
• Promote integration of quality, delivery, service, technical capability, compliance, and business continuity considerations into supplier performance decisions.

• Lead complex, high-impact supplier development and recovery initiatives involving quality, compliance, manufacturing, capacity, delivery, or business continuity risk.
• Partner with suppliers to identify root causes, improve process controls, strengthen quality systems, and increase manufacturing capability.
• Guide the development and execution of supplier quality improvement plans, including clear actions, owners, milestones, success measures, and escalation paths.
• Apply structured problem-solving, Lean, Six Sigma, statistical, and risk-management methods to improve supplier performance.
• Provide technical guidance for process capability, process validation, control plans, critical-to-quality characteristics, measurement systems, statistical process control, defect prevention, and change management.
• Monitor improvement-plan execution and verify the effectiveness and sustainability of corrective and preventive actions.
• Elevate significant supplier quality, compliance, product, patient, or supply risks through established governance processes.

• Ensure supplier development and performance management activities comply with applicable company requirements, quality agreements, purchasing controls, and supplier quality procedures.
• Maintain working knowledge of medical device quality-system and regulatory requirements, including 21 CFR Part 820 Quality Management System Regulation, ISO 13485, EU Medical Device Regulation, and other applicable global requirements.
• Support inspection readiness and provide supplier performance, risk, and development evidence during internal audits, regulatory inspections, and notified-body assessments.
• Partner with Regulatory Compliance, Quality Systems, Supplier Auditing, and business quality teams to address supplier-related observations and emerging requirements.
• Promote consistent application of supplier risk management throughout supplier selection, qualification, monitoring, development, change control, and disengagement.

• Build effective partnerships with Supplier Quality, Procurement, Supply Chain, Manufacturing, Engineering, Research and Development, Regulatory Affairs, and Quality Systems.
• Influence senior stakeholders and supplier executives to align priorities, resources, timelines, and accountability for improvement.
• Lead cross-functional teams without direct authority and create clarity in complex or ambiguous situations.
• Serve as a quality partner in strategic sourcing, network optimization, new-product introduction, product or process transfer, and supplier-change initiatives.
• Coach supplier quality professionals and cross-functional partners in supplier development and performance management methods.
• Promote knowledge sharing, standardization, and replication of successful supplier improvements across the enterprise.

• Continuously improve supplier development and performance management processes based on business needs, regulatory expectations, lessons learned, and external best practices.
• Partner with analytics and digital teams to improve data quality, reporting, predictive risk identification, and decision support.
• Establish a knowledge-management approach for supplier development outcomes, leading practices, and reusable improvement solutions.
• Identify opportunities to simplify governance, eliminate non-value-added activity, and improve the speed and effectiveness of supplier interventions.
• Track program outcomes, including quality improvement, risk reduction, defect prevention, supply continuity, cost avoidance, and capability maturity.

• Bachelor’s degree in Engineering, Science, Quality, Manufacturing, Supply Chain, or a related technical discipline.
• Minimum of 10 years of progressive experience in Quality, Supplier Quality, Manufacturing, Engineering, or Supply Chain within the medical device, pharmaceutical, combination-product, or another highly regulated industry.
• Minimum of 5 years of experience in supplier quality, supplier development, supplier performance management, external manufacturing, or a closely related discipline.
• Demonstrated experience leading complex, cross-functional initiatives through influence rather than direct reporting authority.
• Experience developing and implementing supplier improvement plans and verifying sustainable results.
• Working knowledge of medical device quality systems, purchasing controls, supplier controls, risk management, process validation, and applicable regulatory requirements.
• Experience using data, metrics, and statistical methods to identify trends, prioritize risks, and support decisions.
• Experience communicating with senior leaders and supplier executives.

• Master’s degree in Engineering, Business Administration, Quality, Supply Chain, or a related field.
• Experience operating in a global, matrixed medical device organization.
• Experience establishing an enterprise or multi-site supplier development or performance management program.
• Experience supporting regulatory inspections, notified-body audits, or supplier-related compliance assessments.
• Experience with new-product introduction, product or process transfer, network optimization, or external manufacturing.
• Lean Six Sigma Green Belt or Black Belt certification.
• ASQ Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Certified Quality Auditor, or equivalent certification.
• Project Management Professional certification or equivalent project/program management training.

• Strong knowledge of supplier quality management, supplier lifecycle controls, supplier risk management, and performance governance.
• Strong understanding of 21 CFR Part 820 Quality Management System Regulation, ISO 13485, EU Medical Device Regulation, and applicable current good manufacturing practices.
• Demonstrated capability in root-cause analysis, corrective action, process capability, statistical process control, process validation, measurement systems analysis, control plans, and risk-management methods.
• Ability to translate complex data and technical issues into clear business implications and actionable recommendations.
• Strong strategic thinking, program leadership, project management, and change-management skills.
• Exceptional influencing, facilitation, negotiation, and stakeholder-management skills.
• Ability to establish credibility with technical experts, senior leaders, and supplier executives.
• Strong written, verbal, and presentation skills.
• Ability to manage multiple priorities, operate independently, and make sound decisions in a fast-paced global environment.
• High level of integrity, judgment, accountability, and commitment to patient safety, product quality, and compliance.
• Financial and business acumen sufficient to evaluate investments, prioritize resources, and articulate the value of supplier improvement activities.

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