Sr Mgr Quality Assurance

Johnson & Johnson Innovative Medicine•Jacksonville, FL

2d•$122,000 - $212,750•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

MBA preferred.

Responsibilities

Serves as local Quality Systems Management Representative for the Jacksonville IOL site.
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.
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.
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.
Reports to Executive Management on the effectiveness of the Quality Management System and any need for improvement.
Ensure the promotion of awareness of applicable regulatory requirements and Quality Management Systems requirements throughout the organization.
Ensures that processes needed for the Quality Management System are documented.
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.
Provides coaching and staff development, manage performance, succession planning, and departmental budget. Is accountable for organizational capabilities to meet current and future business needs.
Serves as a technical expert for functional area, with conceptual knowledge of all quality functions and business areas.
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.
Directly supports the design and deployment of Quality Systems improvements, standards and policies at site level.
Observes all Company’s Environmental, Safety, and Industrial Hygiene policies and regulations.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year