J&J Family of Companies Director, Quality Systems in Jacksonville, Florida

Johnson & Johnson Vision is currently recruiting for a Director of Quality Systems to be located in Jacksonville, Florida.

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

This senior level position is responsible for establishing and maintaining efficient and innovative quality systems and solutions to enable compliant growth and robust high quality products.

  • The Director, Quality Systems works closely with the Sites Quality Directors in creating innovative quality systems for product launches, support and business needs.

  • As a primary responsibility, drives all aspects of the quality systems including validation, nonconformance, complaint handling, CAPA, QRB, risk management, and change control, ensuring that all products manufactured under the organization franchise worldwide meet the product requirements.

  • Provide support for FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including pre- and post-inspection support, as requested.

  • Serve as company representative during regulatory inspections.

  • Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.

  • Represent JJVC on JJQS&S Quality System and Regulatory Compliance teams and working groups. Provide input into JJQS&S sector initiatives.

  • Interpret and integrate resulting sector policies and standards into JJVC global operations.

  • Accountable for compliance in accordance with regulations such as, but not limited to, FDA Quality system Regulation 21 CFR Parts 820; ISO 13485, FDA Combo Regulation 21 CFR Parts 4; Current Good Manufacturing Practice (CGMP) regulation 21 CFR 210/211 as applicable.

Other responsibilities include:

  • Adheres to environmental policy and procedures and supports department environmental objectives.

  • Leads and directs Quality System department, manages the development and performance of assigned staff. Ensures the department's objectives and accomplishments meet the organization's goals and strategic plan.

  • Drives the development and deployment of innovative global policies, requirements, and strategies for quality systems.

  • Provides leadership in establishing systems to support the Quality Systems vision.

  • Ensures resources are available to support quality systems.

  • Interfaces with Regulatory personnel during government or corporate audits.

  • Performs other related duties as assigned by management.

Quality Leadership Development Common Skills:

Masters Complexity –

  • Defines and implements department or segment strategies, and serves as an authority to the business.

  • Establishes and has accountability for technical standards for department.

  • Understands and maintains the interrelationships among functions and with other business areas.

  • Serves as technical representative for department.

Innovation–

  • Identifies and manages risks and business needs.

  • Ensures the development and implementation of leading edge quality systems and practices internally/across sites.

Customer Focus–

  • Develops and ensures departmental or divisional initiatives maximize customer value at lowest cost.

Interdependent Partnering–

  • Sponsors departmental and cross-functional team development.

  • Removes barriers.

  • Provides project leadership or participates as a team member on major initiatives that have high impact to the business.

  • Key member of leadership team.

  • Applies influence across departments and the business.

Organizational & People Development–

  • Accountable for organizational depth to meet present and future business needs, looking across J&J companies.

  • Serves as a change agent for global effectiveness.

Qualifications

Qualifications:

  • Bachelor’s Degree is required.

  • 10-12 years industry experience working in a regulated industry (medical device and/or pharmaceutical preferred) with at least 5 years in Quality is required.

  • Complete understanding and application of principles, concepts and practices of production manufacturing and Quality procedures.

  • Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas.

  • Thorough knowledge of 21 CFR 820 and ISO 13485.

  • Working knowledge of foreign medical device quality system requirements.

  • Demonstrated success in the design and deployment of innovative quality systems.

  • Demonstrated success in leadership development.

  • CQE and/or Six Sigma Black Belt Certification.

  • Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control and Applied Statistics. Data driven.

  • Ability to handle multiple projects simultaneously and to discern major quality issues.

  • This positions requires 10-20% international/domestic travel.

Primary Location

United States-Florida-Jacksonville

Organization

Johnson & Johnson Vision Care, Inc. (6094)

Job Function

Validation

Requisition ID

1449170518