Senior Quality Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 were 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 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.

Job Responsibilities:

Supplier Quality Leadership

• 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.

Strategy & Deployment Leadership

• 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.

Qualifications Education:

• A minimum of a bachelors degree in engineering or science discipline is required.

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/ISOCFR 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.

Preferred:

• 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.

Other

• This position may require up to 10% of domestic and/or international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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