Manager, External Manufacturing & Supplier Quality
Company: Disability Solutions
Location: Irvine
Posted on: October 10, 2024
Job Description:
Johnson & Johnson is currently recruiting for a Manager,
External Manufacturing & Supplier Quality! This position can be
located in Irvine or Milpitas, CA.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/.The Manager, External
Manufacturing & Supplier Quality is highly independent and
accountable for providing overall Quality leadership in the
management of J&J Surgical Vision External Manufacturers and
their sub tier suppliers.\rThe Manager, Supplier Quality builds
business partnerships with suppliers and internal stakeholders /
technical experts (i.e. Procurement, Operations, Supply Chain, NPI)
to identify and eliminate supply chain risks, while implementing
continuous and innovative improvements with demonstrated and
measurable results. The manager is accountable for staffing and
talent development within the EM organization. This includes
creation and fulfillment of an effective structure, attracting and
developing key talent.The position is individually and/or through
direct reports accountable for:
- \r
- Providing sound, risk-based QA direction and independent and
timely decision-making on a wide range of quality and compliance
issues
- Ensuring complaint execution of Quality Management Systems
including but not limited to EM: selection, change control,
qualification, the approved supplier list, NC/CAPA, Quality
agreements and performance monitoring.\r\rKey Responsibilities:Risk
Identification and Issue Resolution: Leads activities associated
with supplier risk identification & management, including planning
and execution of supplier risk & control plan assessments. Develop
and utilize Leading Indicators to ensure timely identification of
risk/business challenges and opportunities. Trending and monitoring
sources of supplier quality data such as plant non-conformances,
supplier scorecards, and performance metrics to establish proactive
risk mitigation plans, and improve process capabilities while
eliminating sources of supplier variation.Leads activities
associated with resolving supplier quality issues, such as
non-conforming raw materials and/or internal run-ability
challenges. Includes working with suppliers and internal resources
to perform root cause analysis/failure investigations, identifying
and approving of supplier corrective actions, and monitoring
supplier's implementation / effectiveness. Provides oversight and
escalation for product related issues.Supplier Quality Management &
Leadership: Serves as a member of the site management structure,
representing the department in key leadership meetings, activities,
and decisions. Serves as back-up to the Senior Manager or Director
EM & Supplier Quality, leading development and execution of
department strategies, budget planning, personnel planning and
day-to-day department operations.Leads and/or participates within
Enterprise, Sector, or cross functional projects. Develop, deploy,
and continuously monitor progress towards Franchise and Department
OGSM's. Ensure the implementation of effective global supplier
quality systems policies and strategies that align with the supply
chain quality and compliance strategies and regulatory
requirements.Develop and deploy strategies for talent attraction,
staff development, and retention to enhance the talent pipeline and
champion cross-franchise and sector assignments to foster global
leadership development.Performance Management & Continuous
Improvement: Lead activities associated with Internal & Supplier
Quality Process Improvement. This includes development and
maintenance of Supplier Quality metrics, as well as planning for
and participation within Supplier Performance meetings such as
Management Review and Supplier Business Reviews. This individual
actively works with suppliers' management to review on-going
performance, develop and implement quality improvement projects,
quality systems, processes, and procedures, and to identify and
drive best practices activities.General Supplier Quality Assurance:
Collaborates with Supply Chain partners on the evaluation and
approval of new suppliers, participating in select quality audits.
Ensure suppliers technical competency and general compliance adhere
to company requirements as defined in material specifications,
CTQ's, process control plans, quality agreements and other defined
requirements. Assess supplier change notifications and/or
internally led changes, ensuring appropriate risk based actions and
evaluations are executed.Utilizes knowledge of current and emerging
regulations and their impact to manage the supplier quality
management system. Provides quality and compliance guidance for
suppliers including possible 3rd party inspection support.Quality
Leadership Development Common Skills:Organizational & People
Development: Holds people accountable for measurable results.
Provides coaching, useful feedback, and direction to direct
reports/teams. Ensures and measure improvement for development of
staff. Identifies high potential candidates. Fosters harmony within
functional and other areas. Promotes
- \r
- the business value of diverse perspectives. Influences and
persuades to bring about process and technical improvements.
- Team Building: Manage performance, recruit for open positions
and participate in performance calibration, succession planning.
Develop a people development strategy. Coach/mentor to others
within own function and externally.
- Interdependent Partnering - Facilitates successful team
behavior within and across functional area and typically serves in
a project leadership role. Manages relationships externally and
internally for functional area. Builds cross-functional and
cross-departmental support. Fosters overall group
effectiveness.\rMasters Complexity - Defines complex issues;
recommends and guides implementation of functional strategies;
manages departmental/projects day-to-day operations within area of
responsibility. Technical expert for functional area; makes the
complex clear and compelling; conceptual knowledge of all
responsible functions and business areas. Represents the
department/project in providing solutions to difficult technical
issues.Essential Functions/ Responsibilities:1. Supplier Quality
Management & Leadership - Site functional lead excelling at
strategy development / execution and stakeholder alignment /
communication: 30%2. Supply Chain Risk Identification & Issue
Resolution: 30%3. Suppler & Purchasing Control Systems Performance
Management & Continuous Improvement: 30%4. General Supplier Quality
Assurance: 10%5. Enterprise / Sector Projects & Initiatives:
(Embedded within percentages above)6. Accountable as applicable for
compliance in accordance with regulations such as but not limited
to, FDA Quality System Regulation, ISO 13485, EU MD
Directive/Regulations, FDA 21 CRF820, FDA Combo Product Regulation
21 CFR Parts 4 with 21 CFR 210/211 as applicable, Japanese MHLW,
Health Canada, Brazilian ANVISA, Australian TGA for the company's
products including medical devices and combination products\r
Keywords: Disability Solutions, Orange , Manager, External Manufacturing & Supplier Quality, Executive , Irvine, California
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