Senior Quality Manager

Johnson & Johnson•Irving, TX

About The Position

Johnson & Johnson is currently recruiting a Senior Quality Manager to join our Aesthetics & Reconstruction (A&R) organization in Irving, Texas. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech This unique leadership role combines Supplier Quality oversight with Strategy & Deployment responsibilities for the A&R Quality organization. The Senior Quality Manager will ensure the highest standards of quality across our supplier network while driving strategic initiatives that enable operational excellence and compliance. In the Supplier Quality capacity, this leader will implement and maintain Purchasing Control processes for internal suppliers and external manufacturing operations. Responsibilities include managing supplier-related quality systems such as change control, NC/CAPA, Quality Agreements, and specification development. The role will proactively identify and mitigate supply chain risks to improve supplier reliability and performance, while leading and developing a high-performing team of Supplier Quality Engineers. In addition to supplier responsibilities, the Senior Quality Manager will also lead Strategy & Deployment efforts for A&R Quality. This includes translating organizational priorities into actionable roadmaps, orchestrating cross-functional execution, and driving governance and change management to achieve measurable outcomes aligned with business, quality, and compliance goals.

Requirements

A minimum of a bachelor’s degree in engineering or science discipline is required.
A minimum of 10 years of related experience with at least 4 years minimum of people management experience (ideally in medical device).
Experience working within GXP environment and with international standards/requirements including but not limited to: EN/ISO 13485, 21 CFR Part 820/11, ISO 14971, EUMDR, Canadian Medical Device Regulations (SOR/98-282), and other necessary medical device regulations and standards appropriate for this role.
Demonstrated knowledge of manufacturing principles and practices, and procedures.
Component Qualification/Process Validation experience.
Consistent track record on continuous improvement initiatives and improvement methodologies.
Prior manufacturing, plant, or technical background.
Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls.
Demonstrated ability to identify compliance risks and assess business impact.
Ability to deal with complex issues using deductive reason, critical analysis skills and systematic approaches.
Ability to manage complexity and lead a diverse team is essential.

Nice To Haves

Advanced degree.
Project Management Certification
Prior experience with FDA and/or Notified Body inspections.
Direct experience with supplier GMP audits.
Track record with supporting intercompany and/or working closely with external suppliers, on major compliance initiatives
Green Belt or higher rank and/or Certified Lead Auditor (ISO 13485).
Displayed strong and balanced influence management skills to ensure implementation of strategic processes and improvements to quality management systems.
Prior experience in quality systems remediation including responses to regulators and has shown strong leadership in guiding multiple functions in driving effective root cause analysis.
Function as mentor in people development and ensure collaborating closely with their team to build and maintain talent development plans.
A leader with high integrity and trust, willing to negotiate for right solution, providing empowerment to their teams, is effective in managing conflicts, communicates with confidence, drives decision-making based on data and as appropriate balanced risk, and is adaptive to changes.
Build interdependent partnerships, and internal and external relationships.
Strong management skills.

Responsibilities

Implement and maintain Purchasing Control processes for suppliers and external manufacturing operations.
Manage supplier-related quality systems, including:
Change Control
NC/CAPA management
Quality Agreements
Specification development
Supplier Selection & Qualification
Approved Supplier List
Drive identification and mitigation of supplier-related risks to improve reliability and performance.
Tracks and trends key quality indicators/metrics to monitor supplier and QMS performance.
Lead, develop, and mentor a high-performing team of Supplier Quality Engineers.
Partners with internal customers (Sourcing, Planning, QA, Operations, R&D, Regulatory, Distribution, Marketing, etc.) and suppliers and/or external manufacturers to ensure compliance to product requirements, material/component specifications, company procedures, FDA, ISO, etc.
Support audits and inspections related to supplier quality.
Translate A&R Quality strategic priorities into clear, executable roadmaps.
Lead cross-functional deployment of initiatives, ensuring alignment with business, quality, and compliance goals.
Establish governance routines, performance dashboards, and KPI tracking for strategic projects.
Drive change management and stakeholder engagement to ensure adoption of new processes and systems.
Collaborate with global and regional teams to maintain alignment and consistency in execution.
Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans and responsible for communicating business related issues or opportunities to next management level.