Quality Systems Site Manager
Location:
Jacksonville , Florida
Posted:
April 02, 2017
Reference:
3657170302-en-us

Johnson & Johnson Family of Companies is currently recruiting for a Quality Systems Site Manager located in Jacksonville, FL.
 
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
 
With $70.1 billion in 2015 sales, Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 250 Johnson & Johnson operating companies employing approximately 127,000 people and with products touching the lives of over a billion people every day, throughout the world.
 
The Quality Systems Site Manager will be responsible for the management of the site quality systems such as Corrective Actions/Preventive Actions (CAPA), Change Management, and Management Reviews. This will include input into validation, risk assessment, and failure investigations to align with our world class compliance goals.  Partners with the Business Partners to ensure flawless execution of CAPA, Change Management and Management Review processes.  Responsible for providing CAPA, Change Management & Management Review training programs to Internal and External Business Partners (i.e., Operations, Engineering, R&D) and their support systems/groups. 
 
Responsibilities:
  • Ensures programs are well defined, executable, meet customer and business needs, and are in compliance with regulatory requirements and franchise requirements.
  • Accountable for implementing changes to the site quality systems as identified.   
  • Establishes linkages between quality systems, such as nonconformance, CAPA, management review, change management, complaints, validation, risk management, Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.
  • Leads the streamlining and standardization of Johnson & Johnson VisionCare, Inc. (JJVC) quality systems, including but not limited to change management, nonconformance, CAPA, and management reviews.
  • Ensures MD&D and JJVC specific quality metrics overseen by Quality Systems department in Jacksonville, FL meet targets.
  • Responsible for analyzing and monitoring efficiency and effectiveness of metrics associated with above mentioned quality systems.
  • Adheres to environmental and safety policies and procedures and supports department’s safety and environmental objectives.
  • Ensure CAPA, Change Management and Management Review programs are well-defined, executable, and are in compliance with regulatory requirements.
  • Establish and implement CAPA, Change Management and Management Review best practices, policies, processes and procedures at Jacksonville site, including training program. 
  • Review and approve internal CAPA records and Change Requests
  • Manages Business Unit Reviews and Site Management Reviews
  • Lead, coach and develop direct report(s).
  • Supports internal audits as well as external regulatory agency audits
  • Perform other related duties as assigned by management.
 
Masters Complexity
  • Defines complex issues.
  • Recommends and guides implementation of functional strategies.
  • Manages departmental/projects day-to-day operations within area of responsibility.
  • Spokesperson for functional area.
  • 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.

Innovation
  • Resolves and manages technical and tactical operational problems.
  • Establishes key operating practices for department/project and functional area, ensuring cross-functional synergy.
  • Drives innovation within functional area.

Customer Focus  
  • Develops and implements functional area initiatives to delivery customer value at lowest cost.
 
Interdependent Partnering  
  • Mentors and 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.

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.

Qualifications
Requirements
  • Bachelors Degree – Engineering/Computer Science or Business related  discipline is required
  • Masters Degree– Engineering/Computer Science is preferred
  • Minimum 8 years work experience in Validation/Statistics/Process Engineering/Test Method Development within the Medical Device and/or Pharmaceutical industries. 
  • CQE is preferred
  • Mush have an excellent understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Process Validation, CSV/SDLC, GAMP-4/5, Commissioning & Qualification, Root Cause Analysis/Failure Investigation, and the QSR/ISO Regulations
  • Excellent communication, interpersonal, conflict management, and organization skills
  • Strong leadership and coaching skills

Primary Location
United States-Florida-Jacksonville
Organization
Johnson & Johnson Vision Care, Inc. (6094)
Job Function
Quality Systems
Requisition ID
3657170302

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.