Mgr SQ Supply Base Optimization

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

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SECTION 1: JOB SUMMARY*

The Manager Source Quality Supply Base Optimization is a people leader responsible for leading, developing, and deploying a team of Supplier Quality Engineers in support of MedTech supply base optimization strategies and programs. The position provides strategic, technical, and organizational leadership for Source Quality activities associated with supplier selection, qualification, development, product and process transfers, supplier consolidation, supplier exits, stabilization, and transition to base business.

The Manager Source Quality Supply Base Optimization establishes team priorities, assigns resources, manages performance and development, builds organizational capability, and ensures consistent execution of applicable Quality System and Purchasing Controls requirements. The position partners with Source Quality, Procurement, Network Optimization, Supply Chain, Manufacturing, Engineering, Regulatory, Quality Systems, and other business partners to achieve patient safety, product quality, compliance, supply continuity, productivity, and business objectives.

This position serves as the primary Source Quality leader for assigned Supply Base Optimization programs and is accountable for effective quality and regulatory engagement from business-case development through project implementation, stabilization, and transition to sustaining ownership.

SECTION 2: DUTIES & RESPONSIBILITIES*

People Leadership and Organizational Capability

• Lead, manage, coach, and develop a team of Supplier Quality Engineers and, where applicable, contracted resources supporting Supply Base Optimization programs and initiatives.
• Establish clear roles, objectives, priorities, performance expectations, and accountability for team members.
• Translate business and portfolio priorities into resource plans, assignments, development plans, and measurable team deliverables.
• Conduct regular performance and development discussions, provide timely coaching and feedback, recognize strong performance, and address performance or capability gaps in accordance with Company processes.
• Build technical, quality, project-management, leadership, and business capabilities across the team through targeted development plans, mentoring, training, stretch assignments, and knowledge sharing.
• Support workforce planning, talent reviews, succession planning, recruiting, onboarding, retention, and career development for the Supplier Quality Engineering team.
• Create an inclusive, collaborative, accountable, and high-performing team environment that enables employees to contribute effectively across a global, matrixed organization.
• Balance team capacity and demand, assign qualified resources to projects based on risk and business priority, and escalate resource constraints or capability gaps when needed.
• Ensure team members maintain required training, qualifications, and technical competencies and consistently execute work in compliance with applicable Quality System requirements.
• Provide technical and leadership guidance for complex supplier quality, compliance, transfer, validation, and risk-management matters.
• Ensure effective delegation, decision-making, communication, and escalation within the team.
• Maintain accountability for team performance, project execution, quality outcomes, budget or contractor oversight where applicable, and delivery of agreed business results.

Product and Process Transfer Strategy Execution and Program Management

• Lead the Source Quality function for Supply Base Optimization projects, including supplier-related product and process transfers, supplier consolidation, supplier exits, and other network optimization initiatives.

• Provide technical leadership in quality, compliance, supplier controls, risk management, process validation, and transfer execution.

• Lead development and execution of Transfer Quality Plans and associated product, process, supplier-development, qualification, stabilization, and transition strategies.

• Assign and oversee Supplier Quality Engineering resources supporting projects and ensure clear ownership of deliverables, milestones, risks, issues, and decisions.

• Lead quality and compliance risk-management activities and ensure risks are identified, documented, escalated, mitigated, and monitored.

• Ensure compliance with applicable requirements for design change control, process change control, validation, purchasing controls, supplier qualification, product and process transfers, and change management.

• Assess the suitability and maturity of supplier quality systems, manufacturing processes, technical capabilities, and controls for the products and processes being transferred.

• Confirm, analyze, and review quality, compliance, operational, and performance history for new and existing suppliers.

• Lead or oversee supplier onboarding, qualification, development, technical assessments, quality planning, and stabilization activities.

• Partner with relevant Quality and Compliance functions to ensure appropriate engagement, review, approval, and escalation.

• Lead or oversee investigation, escalation, containment, corrective action, and risk reduction for significant quality issues associated with Supply Base Optimization projects.

• Ensure project team members are trained in relevant procedures, strategies, standard work, tools, and quality requirements.

• Maintain effective stakeholder communication and provide concise updates regarding project status, quality and compliance risks, resource needs, decisions, and required actions.

• Establish and monitor project dashboards and metrics for schedule, quality, compliance, supplier performance, risk, financial performance, and stabilization.

• Monitor transferred products and processes through stabilization to verify performance, effectiveness of controls, and readiness for transition to sustaining ownership.

• Provide program-management-office updates and reporting, including schedule, resources, financials, risks, dependencies, benefits, and Quality and Compliance key performance indicators.

• Lead closure of Supply Base Optimization transfer documentation and ensure complete, accurate, timely, and compliant project records.

• Ensure Purchasing Controls and Quality System requirements are effectively implemented during supplier selection, Approved Supplier List activities, product and component qualification, process and product transfer, supplier quality agreement development, receiving inspection planning, and stabilization.

• Ensure decisions appropriately protect patient safety, product quality, regulatory compliance, and continuity of supply.

Supply Base Strategy, Governance, and Standard Work:

• Partner with Procurement, Network Optimization, Supply Chain, Quality and Compliance, Engineering, Manufacturing, and other functions to develop Supply Base Optimization strategies and project plans.
• Define Source Quality resource, communication, stakeholder, and change-management plans for Supply Base Optimization projects and portfolios.
• Establish Transfer Quality Plans and related strategies and translate quality requirements into project scope, resources, cost, schedule, risk, and execution implications.
• Assess project interdependencies and align Source Quality priorities across related business, Quality and Compliance, supplier, and network initiatives.
• Establish governance mechanisms, management routines, decision forums, escalation pathways, and portfolio reviews for Source Quality Supply Base Optimization activities.
• Develop, deploy, and sustain standard work, procedures, forms, checklists, playbooks, tools, templates, and knowledge resources for supplier transfers, supplier development, supplier exits, decommissioning, commissioning, quality financials, and stabilization.
• Maintain effective Quality Management System interfaces for product and process transfer procedures across applicable businesses and franchises.
• Identify opportunities to simplify, standardize, digitize, and continuously improve Source Quality processes and team effectiveness.
• Track performance, lessons learned, and leading indicators and use the information to improve future project planning, supplier decisions, resource allocation, and risk controls.
• Represent Source Quality in cross-functional governance forums and communicate business-related risks, issues, opportunities, decisions, and resource needs to the appropriate management level.

SECTION 3: EXPERIENCE AND EDUCATION*

·        A bachelor’s degree or equivalent in Engineering, Science, Quality, Regulatory, Supply Chain, Business, or a related discipline is required. An advanced degree is preferred.

·        A minimum of eight years of progressive experience in Quality, Supplier Quality, Engineering, Manufacturing, Supply Chain, Program Management, or a related discipline within the medical device, pharmaceutical, combination-product, or another highly regulated industry is required.

·        A minimum of two years of direct people-management experience is required, including demonstrated responsibility for goal setting, performance management, coaching, employee development, talent planning, and resource allocation.

·        Demonstrated experience leading and developing technical professionals, preferably Supplier Quality Engineers, in a global or matrixed organization is required.

·        Demonstrated experience leading complex supplier-related product or process transfers, supplier qualification, supplier development, external manufacturing, supplier consolidation, supplier exits, or network optimization initiatives is required.

·        In-depth knowledge of quality and manufacturing systems, supplier controls, purchasing controls, process validation, change control, risk management, and applicable regulatory requirements is required.

·        Working knowledge of ISO 13485, European Union Medical Device Regulation requirements, applicable United States medical-device quality-system requirements, and current good manufacturing practices is required.

·        Experience managing multiple projects, priorities, resources, and stakeholders and delivering results through both direct authority and cross-functional influence is required.

·        Experience with financial planning, business cases, resource planning, portfolio prioritization, and program governance is preferred.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Demonstrated people-leadership capability, including coaching, feedback, performance management, talent development, succession planning, change leadership, and team building.
• Ability to create clarity, accountability, engagement, and alignment within a technical team operating in a complex, global, matrixed environment.
• Strong technical credibility in Supplier Quality, Quality Engineering, supplier controls, process validation, risk management, and product and process transfer.
• Strong program and project-management capability, including governance, planning, resource management, risk management, decision-making, escalation, and executive reporting.
• Strong business and financial acumen and the ability to translate quality and compliance requirements into practical business, resource, schedule, and risk implications.
• Ability to prioritize and deploy resources based on patient, product, compliance, supply, and business risk.
• Demonstrated ability to influence senior leaders, cross-functional partners, technical experts, and supplier executives.
• Strong communication, facilitation, negotiation, conflict-resolution, and stakeholder-management skills.
• Strong analytical, problem-solving, and data-driven decision-making skills.
• Experience with Lean, Six Sigma, Process Excellence, or structured problem-solving methods is required.
• Project-management certification or formal project-management training is preferred.
• CQM, CQA, CQE, CSQP, or an equivalent quality certification is preferred.
• Ability to operate effectively in a fast-paced environment, manage ambiguity, and lead through organizational and business change.

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