Sr Mgr Quality Assurance

About this role

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

All Job Posting Locations: Jacksonville, Florida, United States of America

Job Description: Job Position Summary Directs the Jacksonville - FL, Johnson and Johnson Surgical Vision Quality Operations organization, ensuring compliance with quality requirements, continuous supply to customers, compliance and regulatory agencies requirements, among others. Responsible for taking a leadership role in defining short and long-term strategies for the Jacksonville facility. Has direct accountability through direct reports, over inspection and release of incoming raw materials, in-process and final Quality inspection and testing. Directs the Quality Engineering team and Quality Systems site execution. Engages and collaborates with Franchise Quality teams as well as cross functional Supply Chain functions including Operations, Makes Engineering, Production Planning and Logistics and Product management to assure a horizontal approach to resources management and prioritization.

Duties & Responsibilities 1.       Serves as local Quality Systems Management Representative for the Jacksonville IOL site. 2.       Operates tactically within the operations environment to ensure practical and timely provision of Quality decision making. Oversees management of the day-to-day quality activities related to the Jacksonville site. Makes decisions on non-conforming material, as required by the Quality System procedures. Evaluates and communicates quality events for elevation to Risk Management Board and/or Quality Board as per applicable procedures. 3.      Develops the site operational Quality strategy as a business partner to Supply Chain Operations and Franchise QA functions to optimize the performance of operations, compliance, and quality systems as well as influence the global integration and alignment of goals across the organization. 4.      Serves as Host for 3rd party audits; participates and presents in Quality and Compliance Executive Reviews, Management Reviews, Quality Boards and others as requested/required. 5.      Reports to Executive Management on the effectiveness of the Quality Management System and any need for improvement. 6.      Ensure the promotion of awareness of applicable regulatory requirements and Quality Management Systems requirements throughout the organization. 7.      Ensures that processes needed for the Quality Management System are documented. 8.      Evaluates Jacksonville’s Quality Operations capabilities, identify gaps, and recommends issue resolution to Executive Management. Develops and leads innovative initiatives to improve business performance to support visionary changes. 9.      Provides coaching and staff development, manage performance, succession planning, and departmental budget. Is accountable for organizational capabilities to meet current and future business needs. 10.   Serves as a technical expert for functional area, with conceptual knowledge of all quality functions and business areas. 11.   Serves as Subject Matter Expert (SME) for execution of Quality Systems in Jacksonville during inspection readiness activities. Supports the preparation of any communications with FDA related to any follow-ups of inspections carried out at the Jacksonville site. 12.   Directly supports the design and deployment of Quality Systems improvements, standards and policies at site level. 13.   Observes all Company’s Environmental, Safety, and Industrial Hygiene policies and regulations.

Experience & Education ·       Bachelor’s Degree - Science/Engineering. MBA preferred. ·       15 years of experience in the Medical Devices or Pharmaceutical sector, with a minimum of 7 years of managerial experience and 5 years in Quality. ·       Experience with FDA/Notified Body agencies. Regulatory experience, including US Class III (PMA) and US Class II regulations, supporting timely and compliant regulatory submissions, inspections and audits.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations ·       Thorough knowledge of 21 CFR 820. ·       Demonstrated success in the design and deployment of innovative quality systems. ·       Ability to influence at senior levels and across functions building strong networks internally and externally. Experience delivering results through influence in a highly matrix environment. ·       Strong experience and proven record motivating, leading and developing staff, in a highly changing environment. ·       Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control and Applied Statistics. Six Sigma.

Location & Travel Requirements Location: JJSV Jacksonville FL Travel:20%

Required Skills:     Preferred Skills: Business Alignment, Collaboration, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

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