Senior Manager Source Quality

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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About MedTech

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 are searching for the best talent for a Senior Manager Source Quality to be located at Juarez Mexico and/or São Paulo Brazil.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States and Puerto Rico - Requisition Number: R-052898

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

The Senior Manager Source Quality manages a group of Source Quality professionals responsible for ensuring that ETHICON Suppliers provide purchased finished goods direct and indirect materials or services that comply with Ethicon J&J Global Regulations and industry standards. Using a risk-based approach manages the Purchasing Control Process and lead the Source Quality Management and control program for ETHICON driving continuous process improvements and ensuring sustainable compliance with Ethicon J&J Global Regulations and industry standards.

You will be responsible for:

• Manage a significant global supplier base consisting of suppliers of Purchased Finished Goods Direct Materials /components and Indirect Materials & Services that impact the quality of products and/or the Quality System for ETHICON.

• Provide people leadership to a group of Source Quality professionals focused on developing people both technical and people-based skills and ensuring that those competencies match both the quality and business needs. Promotes diversity. Accountable for ensuring goals and objectives are met.

• Holds self and people accountable for results achieved through Credo Values and Leadership Imperatives. Removes barriers to people development. Models and fosters people development. Actively champions and supports people development to expand their capabilities skills knowledge and enable movement of talent.

• Drive development of both supplier base and supplier-focused initiatives within the ETHICON Franchise in support of robust compliant products that continuously meet the needs of patients customers and business objectives.

• Identify sponsor and champion Purchasing Control projects and programs ensuring the continuity of product supply as well as applicable Global Regulations and standards.

• Partner with Procurement Manufacturing and R&D to manage and mitigate supplier risk across the product lifecycle.

• Ensure appropriate resource and budget and allocation decisions are made. Takes a leadership role in engaging key stakeholders to scope projects resources budgets and timelines to ensure execution.

• Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Enterprise SQM and Procurement Organizations.

• Develop and utilize Leading Indicators to ensure timely identification of risk/business challenges and opportunities. Analyzes quality system trends identifies issues and seeks appropriate action.

• Leads a portfolio of projects through to support external supply quality systems initiatives. Interacts with stakeholders and sponsors to communicate project status and alignment with business objectives.

• Participates in the external supply selection process to provide quality system expertise.

• Ensures compliance to applicable Global Regulations and standards (e.g. QSR ISO EN and Medical Device Directive (MDD) requirements).

• Serves as Purchasing Controls SME in internal and external audits.

• On behalf of the Director of Source Quality represents the company in contract negotiation and Quality Agreements with external manufacturers and suppliers.

• Escalate patient-safety and compliance risks appropriately.

• Comply with all environmental safety and occupational health policies. (i.e. ISO14001 & OSHAS18001)

• Responsible for communicating business related issues or opportunities to next management level.

Qualifications / Requirements:

• A minimum of a bachelors degree in engineering an Applied Science or a related technical and quality field is required.

• A masters degree is preferred.

• A minimum of 8 years of experience in a regulated industry like Medical Devices Pharma and/or Consumer is required.

• Experience in Quality Systems Purchasing Control and/or Supplier Management is preferred.

• Broad experience with quality systems including but not limited to qualification validation issue investigation non-conformance CAPA systems and investigations laboratory controls production and process controls is required.

• Experience with documentation and technical writing skills in a regulated compliance environment is required.

• Prior experience with Regulatory/FDA inspections is desirable.

• A minimum of 4 years of managerial experience is required.

• Hands-on experience in strategy development and deployment experience preferred.

• Computer literacy in the use of business software applications including Microsoft Office (Word Excel PowerPoint) is required.

• Working knowledge of regulatory compliance requirements (QSR MDD ISO 9001 ISO13485 ISO 14971 and other international standards).

• Working knowledge of issue investigations Non-Conformance Reports (NCRs) Corrective and Preventative Actions (CAPAs) and Internal/External Audits is preferred.

• Demonstrated strong business acumen organizational and leadership skills required

• Excellent verbal and written communications skills required.

• ASQ Certified Quality Engineer (CQE) Manager of Quality/Organizational Excellence (CMQ/OE) Supplier Quality Professional (CSQP) preferred.

• ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA) preferred.

• Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified preferred.

• Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training preferred.

• Fluent English mandatory; Spanish Portuguese or German desired.

• Ability to collaborate with all levels of management in cross-functional team environment is required.

• This position may require up to 35% domestic and 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.

Required Skills:

Preferred Skills: