Director, Global Quality Escalation Center of Excellence Lead
Location:
Raritan , New Jersey
Posted:
April 02, 2017
Reference:
0000197A-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 Director, Global Quality Escalation Center of Excellence Lead to be located at any Janssen facility worldwide.
 
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.
 
:
 
  • Provide strategic, organizational, and operational leadership for the quality incident escalation/notification and issue management process(es) for all Janssen Quality & Compliance (Q&C), including product and non-product events. 
  • Manage all process and system components of the escalation/notification and issue management activities that fall in scope of the quality escalation procedure and includes SOP governance, process measurement and improvement, and oversight of escalation/notification document management. 
  • Provide consultation and advice to global and region staff (APAC, EMEA, LATAM and the US/Canada marketplace) for all product and non-product issues to ensure compliance to the process. 
  • Manage a network of escalation coaches [through a Center of Excellence (CoE)] who provide support/advice on execution of the issue/escalation processes to ensure compliance.
  • Function as the Operating Chair for the Quality Review Board, providing operational support to activities that need to be managed for decision making by the Quality Review Board (QRB) which fall in scope of the escalation procedure. 
  • Janssen process owner of the quality escalation/notification system and trending tools. This role approves all system changes and is the subject matter expert for the associated processes and systems.
  • Represents Janssen with internal and external auditors on the general topics of the quality escalation process and system.
  • Provides/oversees training to staff and business partners on use of the quality escalation system.
  • Partners with all Janssen Q&C organizations to ensure continued robust end to end escalation process performance, providing escalation metrics and trending data to the various Q&C organizations for evaluation (i.e., QSMRs, functional, product, etc), and oversees conduct/completion of product recall activities.
  • Drives/participates directly or indirectly on regional and global escalation initiatives, to develop, consolidate, and/or improve quality escalation and related/interfacing processes.
  • Leads, coaches and mentors a network of escalation coaches globally

Qualifications
 
  • A minimum of a Bachelor's Degree is required, advanced degree preferred.  A focused degree in Bio Science or equivalent field is preferred. 
  • A minimum of 10+ years of work experience in a pharmaceutical and/or medical device industry and 7+ years working in a quality, compliance and/or regulatory function is required.
  • Process Excellence experience preferred
  • Track record of leading or coaching teams and driving results is required
  • Change management experience is preferred
  • Experience working in a global or regional context desired
  • Ability to effectively present information to Management and large groups is required
  • Demonstrated knowledge and expertise in quality processes and regulatory requirements is required
  • Experience managing a quality or compliance function is required
  • Strong knowledge of GxP Regulations is required
  • Knowledge of FDA inspection guide for Quality Systems Inspections is preferred
  • Experience in issue management, including investigation and CAPA management is required
  • Experience with tools and techniques supporting qualitative risk analysis including but not limited to: Probability and impact assessment (likelihood of recurrence and potential effect), probability and impact matrix (risk ratings, rating rules), and risk categorization (by root causes, other qualifiers) is preferred
  • Experience with systems and tools supporting analysis and reporting is preferred
 
This position can be based at any Janssen facility worldwide, and may require approximately 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-New Jersey-Raritan
Other Locations
North America, Europe/Middle East/Africa, Latin America, Asia Pacific
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Assurance
Requisition ID
0000197A

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