Senior Manager Source Quality

Johnson & Johnson Innovative Medicine•San Angelo, TX

23h

About The Position

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 https://www.jnj.com About MedTech 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 We are searching for the best talent for a Senior Manager Source Quality to be located in Guaynabo, PR, Cornelia, GA, San Angelo, TX and/or Raritan, NJ. 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): Brazil and Mexico - Requisition Number: R-053884 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.

Requirements

A minimum of a bachelor’s degree in engineering, an Applied Science or a related technical and quality field is required.
A master’s 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.

Responsibilities

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.