Senior Director, Global Complaint Vigilance
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
00001981/2-en-us

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  We are currently recruiting for a Senior Director, Global Complaint Vigilance, to be based in one of the following locations:  Raritan, NJ; Titusville, NJ; Horsham, PA; High Wycombe, UK; or Beerse, Belgium.
 
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world.  With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
 
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management.
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
 
  • Design and sustain the Global Complaint Vigilance Management process in the Business Quality organization. Ensures integrity, consistency, and compliance of complaint records to comply with 21CFR Part 210-211, 21CFR Part 4 and Part 820 and ICH Q10.
  • Sets clear direction for a sustainable Global Complaint Vigilance process execution (including holistic investigations, proactive reporting-trending-surveillance, preparation for MDR reporting) in conformance to current standards and procedures, using applicable system application tools (e.g., PQMS, Trackwise).
  • Provide clear guidance to the entire Janssen organization (Intake Units, Investigational Sites, Global Medical Safety) in gathering accurate data, performing holistic investigations as per regulation and be able to do proactive interpretation of data and trend detection and identify CAPAs to prevent reoccurrence of the reported cases.  Ensure alignment between local, regional and global processes for overall Complaint Management Process. Follow up on metrics to ensure adherence to the standard processes.  Ensure appropriate risk management strategies are integrated in End-to-End Complaint Management Process.
  • Ensure appropriate metrics/ Key Performance Indicators are defined, measured and analyzed to ensure process compliance and continuous improvement opportunities and follow up of process execution performance.
  • Identify and work out areas of improvement for End-to-End Complaint Management Process with organizations such as Marketing, Business Quality, Global Medical Safety, Global Medical Affairs, Intake centers, internal/external business partners to ensure the integrity, consistency, and compliance of the process. Manages process alignment with organizations and processes that interface or depend on Product Quality Complaint management.
  • Partner with other areas of Quality Systems to support the development, deployment, automation, and maintenance of a single set of standardized quality system processes and to create systems for compiling metrics and trending of customer complaints and adverse events to proactively identify product trends.  Partner with different groups in the Pharma Quality organization to drive the organization to decision making based on complaint trends evaluation and complaint investigations.
  • Leads staff of globally dispersed professionals who are process owners of the global End-to-End Complaint Vigilance process, and who train, monitor and coach process users. The staff participates directly or indirectly on project teams to develop, consolidate, and/or improve complaint vigilance processes.  Leads and mentors, coaches a staff of professionals who are process execution owners of the global complaint vigilance process
  • Works closely with Global Regulatory Compliance to track health authority inspection results and assesses internal processes for potential gap and provides support to ensure proactive compliance with emerging trends. Drives resolution of identified gap and complaint vigilance issues ensuring cross-function/organization alignment by defining and leading projects that address stakeholder requirements.
  • Responsible for the development of all employees within the department by using the tools provided by Human Resources including management development and training to meet current and future business needs. Provides an environment that encourages the company’s commitment to equal employment opportunity and the value of a diverse work force.
  • Ensures sufficient resources are available to execute the sustainable End-to-End Complaint Management Process.

Qualifications
  • A minimum of a Bachelor’s Degree is required, an advanced degree is preferred.  A focused degree in physical or life science is preferred.
  • A minimum of 15 years of related experience, including significant experience working in pharmaceutical, consumer, medical device or other related or highly regulated industry is required
  • A minimum of 5 years of experience in managing professional level associates and managers is required
  • Demonstrated knowledge and expertise in global regulatory requirements, including 21CFR Part 210, 211, 610, 820 and ICH Q1 is required. Ability to evaluate processes and recommend and realize improvements to efficiently meet regulatory requirements is required.
  • Ability to lead projects, collaborate across multiple functions to continuously improve end to end complaint vigilance process is required.  Ability to determine and assign resources and individual tasks is required. Ability to develop and implement simple and effective complaint vigilance systems and metrics is required.
  • Demonstrated understanding of manufacturing processes, investigation execution and associated GMP compliance requirements is required. Ability to apply this knowledge to lead and develop process strategies for global needs is required.
  • Process excellence certification (Green Belt, Black Belt), ASQ Quality Manager certification, or Project Management certification (PMP) is a plus.
This position can be based in one of the following locations:  Raritan, NJ; Titusville, NJ; Horsham, PA; High Wycombe, UK; or Beerse, Belgium and may require up to 25% domestic/international travel.
 
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
 

Primary Location
United States-Pennsylvania-Horsham
Other Locations
North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality (Generalist)
Requisition ID
00001981

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.

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