Senior Director, Supply Chain Quality- Electrophysiology (EP) - 2406218052W

Description

Biosense Webster Inc. is recruiting for a Senior Director, Supply Chain Quality - Electrophysiology (EP) to be located in Irvine, CA, El Paso, TX, or Irving, TX. Other Johnson and Johnson MedTech sites in the United States will also be considered.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

The Senior Director, Supply Chain Quality – Electrophysiology (EP) is responsible for the Electrophysiology Supply Chain Quality Operations, processes and systems associated with the internal manufacturing sites (Salvarcar, Horizontes) as well as the external suppliers; Indirect, Direct, and External Manufacturers.

Responsible for driving End to End Supply Chain Quality Execution governance, synergies and optimization across applicable network including development and execution of Operational Excellence Strategy across all sites within the platforms. This role will have overall management responsibilities for both financial and talent including planning for current and future business needs.

In addition, the incumbent will develop and execute supplier capability improvement program, working with the J&J MedTech Supply Chain Center of Service (CoS) leaders to ensure initiatives are identified, resourced, completed and measured. He/she will gather data insights and proactive risk measures to identify areas of concern and leverage/execute capability tools/programs to proactively mitigate risk areas to improve Supplier and Strategic Collaborator Reliability.

Responsibilities:

Site(s) Quality Operation

• Oversees the quality activities for the Cardiovascular Electrophysiology manufacturing facilities. Establishes one Quality Leader with receiving to shipping dock “accountability” including but not limited to; Supply Chain Continuity, Finished Good Product Release, Compliance Readiness Activities, Inspection Execution, Quality System Execution (NC/CAPA/CAPs) and Quality Engineering.

• Partner with Supply Chain to effectively develop and deploy the Supply Chain & Quality strategic plans and assure the integration/alignment of the quality operations strategy at the business level

• Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards.

• Ensures plant(s) assess QS effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate.

• Oversight and responsibility for complete and correct manufacturing related complaints investigations. Ensures customer feedback and complaints are address in appropriate and timely manner.

• Executes responses to field actions and coordinates global response with the ETE Franchise Quality leadership and corporate functions.

• Champions a Customer Centric Quality culture sustained by the systemic implementation of Lean

Strategies to Quality Business processes to drive Continuous Improvement and Compliance, while delivering Value Enhancing solutions.

• This individual has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.

• Establishes and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business.

Source Quality- Indirect, Direct and External Manufacturer

• Establish and execute the Quality Strategy for supplier management.

• Establish, manage, maintain, and continuously improve all Quality activities associated with suppliers.

• Drive quality performance improvements by developing quality capabilities and developing and implementing quality improvement plans

• Active participant in the selection, performance management, and disengagement processes

• Partners with MedTech Supply Chain Quality CoS, Sourcing and Enterprise Source Quality to develop the supply base strategy and to ensure effective management of the suppliers assigned businesses.

• Partner with Business R&D and Design Quality to ensure new product sourcing and supplier controls are implemented in line with business and J&J requirements.

• Administer health authority, MD, and J&J policy requirements and standards to ensure the proper balance of business and compliance needs. Manage this balance to optimize continuous compliant growth within supply base.

• Ensures execution of compliant purchasing controls.

• Facilitates the resolution of quality issues affecting the compliance and/or supply continuity of goods sourced.

• Support Regulatory body audits at internal sites and suppliers as required.

• Provide Supplier Quality Engineering support including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management as required

• Accountable for tracking and reporting of executed initiatives and associated improvement measures and targets.

• Identify and lead opportunities for proactive quality including intelligent automation opportunities and quality improvement projects

• Defining regular reporting and updates to ensure visibility (risks & mitigation, Quality & Compliance KPIs, etc.)

Qualifications

Education:

• Bachelor’s Degree is required with a preferred area of study in Quality/Regulatory, Business, Engineering, or Science

• MBA or Master's degree is preferred.

Experience and Skills:

Required:

• A minimum of 12 years of Quality experience in a regulated environment is required.

• A minimum of 5 years in a supervisory/manager role or above in Quality or Compliance function is required.

• Experience in external manufacturing or Supplier Quality is required.

• Strong influencing skills with ability to see issues from multiple viewpoints and understand differing needs of stakeholders

• Executive presentation & facilitation skills with the ability to drive decisions and influence multiple stakeholders and partners

• Strong understanding of Purchasing Controls and innovative applications for various risk management and risk mitigation tools

• Proven ability to identify and manage risk, including escalation, prioritization and resolution of Quality issues.

• Demonstrated strong communication (verbal, written and visual) and networking ability at a global level to execute with cross-functional stakeholders/partners and ability to influence without authority.

• Strong business acumen, including demonstrated experience in identifying and leveraging analytics and data for business problem solving

• Demonstrated ability to lead through change and serve as a change agent

• Must be able to translate project/technical outcomes into execution and appropriate reporting, dashboard/scorecard formats

• In-depth knowledge of quality and manufacturing systems and processes and applicable regulations, i.e. ISO 13485, FDA’s GMPs for medical devices

Preferred:

• Experience in more than one of the following preferred (cross-sector): Consumer Products, Medical Devices and Diagnostics, Pharmaceuticals.

• CQM, CQA or CQE Certification from the American Society for Quality (ASQ) or equivalent.

• Experience in Supply Chain, Commercial, and/or R&D.

• Experience with Six Sigma/Process Excellence tools, training and certification is preferred.

• Experience with ideation events and/or in innovation methodologies (ex = Design Thinking, Agile, Lean etc.)

Other:

• 35% international and domestic travel

The anticipated base pay range for this position is $163,000 to $282,900.

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)).

• This position is eligible to participate in the Company’s long-term incentive program.

• 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; for employees who reside in the State of Washington – up to 56 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

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 10/23/24. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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-Texas-Irving, NA-United States, NA-US-Texas-El Paso

Organization Biosense Webster Inc. (6010)

Job Function Quality Assurance

Req ID: 2406218052W