Senior Director Post Market Surveillance (PMS) & Business QA in Consumer Medical Devices
Location:
Jacksonville , Florida
Posted:
April 02, 2017
Reference:
2874170221-en-us

Johnson & Johnson Vision Care, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Sr. Director, Post Market Surveillance (PMS) & Regional QA in Consumer Medical Devices located in Jacksonville, Florida.
 
Johnson & Johnson Vision Care (“JJVC”) specializes in disposable contact lenses, which it markets under ACUVUE® Brand Contact Lenses. Ever since the ACUVUE® Brand transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
 
This new position of Sr. Director, Post Market Surveillance (PMS) & Regional QA in Consumer Medical Devices is accountable for overall strategy, execution and oversight of all activities associated with complaint handling associated quality management systems, functions and regulatory compliance reporting of Adverse Events (AEs) and Medical Device Reportable (MDRs) throughout the product life cycle for J&J Vision for the Surgical business, globally.
 
  • This position is responsible and accountable for all legacy Vision Care regional QA offices and distribution centers, globally. Accountability includes compliance to J&J Policies, global quality system, and regional regulatory requirements.  Ensures successful internal and external inspections and audits for all regional QA offices and distribution centers for area of accountability.
  • Ensure timeliness of all complaint handling, adverse events, and medical device reporting activities in accordance to procedures, standards and regulations.
  • Ensures compliance with J&J Policy, Standards and Regional government regulations for areas of accountability.
  • This key leadership role is to ensure governmental regulatory requirements are met, customer experiences are appropriately logged and investigated to both comply with laws/regulations.  This position will facilitate proactive quality and associated improvements in customer experience, as well as to ensure the organization is informed of adverse trending through analysis of complaints for Adverse Events, Medical Device Reportable, including tracking and trending.
  • Assures compliance with regards to AE/MDR with the applicable international regulatory requirements (ie, FDA QSRs, ISO 13485, Japanese MHLW, Brazilian ANVISA, EU MDR) for the company's products, including medical devices, and combination products. Participates as SME in external (FDA, ISO) and internal audits as required
  • Direct leadership accountability and oversight of activities such as (a) uptake and logging of customer complaints, (b) their proper and thorough investigation and subsequent documentation, (c) statistical tracking and trending and associated evaluation and escalation of adverse customer complaint trends and early identification of new issues (with priority on safety issues), (d) proper evaluation of safety and patient risk through overall administration of a Health Hazard Evaluation (HHE) process, and (e) AE and MDR reporting, and the associated timeliness.
  • The Sr. Director, PMS & Regional QA, is responsible for cross functional teams that evaluate product risk and potential safety issues.  The teams will assess serious injuries and malfunctions in support of regulatory agency product surveillance requirements and ensure the timely initiation and completion of HHEs and regulatory filings if applicable.
  • This position will hire, develop and organize a department of regulatory, medical clinician and technical professionals such that the team meets all safety, regulatory and quality requirements in an efficient, process, results oriented manner. 
  • This position will work closely with Medical Safety Office (MSO) and their staffs to ensure consistency in medical evaluations are performance and documented in HHEs and safety evaluations of products.
  • This position will work in partnership with Commercial Operation entities (Customer Service, CLS, R&D, Regulatory, Manufacturing, Legal, Quality, etc) in resolving customer issues and developing continuous process improvement initiatives.
  • This position will develop and implement programs to review literature and internet for potential complaints and AE/MDRs. Evaluates target product profiles and presents summaries of product characteristics for new products entering development.
  • Responsible and accountable for all global PMS procedures, local work instructions, practices and compliance of complaint and reporting performance.
  • Responsible to ensure all IT systems facilitating organizational execution of PMS duties are efficient, validated and in compliance as applicable.
  • Directly accountable for all related PMS Quality & Compliance metrics including Complaint cycle times, timeliness, on-time AE and MDR reporting, complaint update and call center efficiency and customer satisfaction metrics.  Accountable to ensure HHE work streams are efficient, adequately documented and timely.
  • Serves as a Core leadership team member reporting directly to the VP and Chief Quality Office (CQO), CMD.
  • Promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization.  Supports departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
  • Ensures talent development processes are implemented and executed to maintain a healthy pipeline of PMS talent for CMD Eye Health PMS organization.  
  • Partners with R&D QA to ensure new products consider regionally specific User Needs.
  • Responsibility will include strategy and implementation of new tools and technologies such
  • Leadership responsibility and accountability for all Post Market Surveillance processes and implementation of those processes such that products and services achieve outstanding results in customer service, satisfaction, experience and compliance.
  • Responsible and accountable for the compliance of all PMS processes and procedures, associated document and performance metrics.  Responsible areas must always be FDA inspection and ISO audit ready.
  • Responsible and accountable for associated PMS and Regional QA strategic plans and financial planning activities to ensure effective and efficient global PMS and Regional QA operations.
  • Directly accountable to VP and CQO and CMD Group Chair for outstanding business and compliance results within CMD Sector.
  • Scope of responsibility includes compliance of all customer complaint and customer service call centers that have the direct or indirect accountability of discerning and logging a customer complaint or urgent safety issue.
  • Direct responsibility and accountability for all operational aspects of Eye Health complaint call center, handling, investigations, risk management, safety evaluations, timely reporting and escalations of adverse performance and/or safety trends.
  • Ensure field performance and safety issues are properly addressed for new product requirements and/or risk management files.
  • Ensures successful Regional QA compliance audits by internal J&J and external auditors and FDA investigators.
  • Responsible to recruit and further develop high caliber Quality and Compliance professionals.

Qualifications
  • Bachelors Degree – Engineering, Applied Science Discipline, Clinical, Medical.  Advanced degree desirable.
  • >12 to 15 years of working experience in Medical Devices and/or health care safety/risk management operations. It is mandatory that the successful candidate have served in a leadership role as head of a complaint handling and investigation and reporting operation in a global medical device organization. Experience to include a minimum of 10 years management experience.
  • Strong communication, organizational, collaboration and interpersonal skills.
  • Pragmatic and open minded collaborator (within and cross functionally).
  • Must have FDA inspection experience in front room, defending records and/or presenting PMS processes overviews. Strong business and process efficiency acumen required.
  • Must have a proactive nature to ensure problems and issues are avoided.
  • Must have a strong sense of urgency.
  • Understanding of PMS requirements of Combination Products.
  • Proven track record of results and strong leadership capabilities.
  • Knowledge, understanding and application of quality and regulatory compliance principles, concepts and practices related to quality systems regulated by domestic and foreign governments, especially in the areas of complaint handling, investigations, safety and risk management.
  • Understanding and working knowledge of a broad set of regulations and standards (21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL, etc.)
  • Up to 50% international travel is required.
  • This position will be located in Jacksonville, FL.

Primary Location
United States-Florida-Jacksonville
Organization
Johnson & Johnson Vision Care, Inc. (6094)
Job Function
Quality Systems
Requisition ID
2874170221

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