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Manager, External Manufacturing & Supplier Quality - 2406216388W

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.

The 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:

• 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.

Key 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

• 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.

Masters 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

Qualifications

Education:

A minimum of a Bachelor’s or equivalent University degree is required, with a focus in technical/scientific degree in Engineering or Sciences is preferred.

Required:

• A minimum of 8 years of Medical Devices and/or P (or similarly regulated industry) experience is required. A minimum of 5 years of responsibility and experience in application of current Good Manufacturing Practices.

• Experience developing and managing supplier quality programs is highly preferred. Certification as a Quality Engineer, Quality Manager and/or Quality Auditor is preferred. Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred. Strong computer skills and use of software application(s) (MS Word, MS Excel, MS PowerPoint, MS Visio, MS Project, Minitab.

• This candidate will have demonstrated leadership, negotiating and influencing skills to achieve results through others with and without direct authority. Demonstrated ability to develop and implement strategy/initiative based on business needs is required. Strong organizational and analytical skills to comprehend technical data/information and convert them into value-added actionable items are required. Ability to effectively utilize key knowledge of business processes, analytical tools and the regulatory environment in support of the supplier quality management lifecycle.

Preferred:

• Understanding and knowledge of a broad set of regulations and standards ISO 13485, EU MD Directive/Regulations, FDA 21 CRF820, FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA.

Other:

• This position may require up to 25% of domestic & international travel.

The anticipated base pay range for this position is 100,000-172,500. California Bay Area - The anticipated base pay range for this position is 114,000-197,800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.

Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

-Vacation – up to 120 hours per calendar year

-Sick time - up to 40 hours per calendar year; Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability

Primary Location NA-US-California-Irvine

Other Locations NA-US-California-Milpitas

Organization Johnson & Johnson Surgical Vision, Inc (6234)

Travel Yes, 25 % of the Time

Job Function Supplier Quality

Req ID: 2406216388W