Director, Product Quality Management
Location:
Malvern , Pennsylvania
Posted:
December 20, 2016
Reference:
00001765/3-en-us

Janssen Supply Group, LLC is currently recruiting for a Director, Product Quality Management to be based at one of the following sites: Cork, Ireland; Leiden, Netherland; Geel or Beerse, Belgium; Raritan, NJ; Springhouse or Malvern, PA; Schaffhausen, Switzerland or Latina, Italy.

 

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.  

 

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. Please visit www.JanssenPharmaceuticalsInc.com for more information.

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 
The Director, Product Quality Management will:
 
  • Have end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products.
  • Coach a group of Quality Owners inside of PQM Product Quality Management (PQM) and Quality Owners in the different sites and develop standardized processes to:
    • Ensure the Quality owners are a key member of the Value Stream team and respective sub teams.
    • Ensure processes are designed and executed to have key decisions on products proposed/decided by the Value Stream Teams (VST) teams.
    • Proactive Product Quality Scans are implemented into the Life Cycle Management of each product.
    • All product related changes are initiated and evaluated by Value Stream Teams (VST) teams.
    • Ensure VST teams involved in CAPA processes if product is related and initiate continuous improvements in all areas of the product (process, testing, handling, etc.) through a rigorous review of information such as Batch records, CAPA, APR, reconciliation reports, rejects, reworks, spec mgt, etc.
    • Products are managed from cradle to grave including managing issues on the market.
    • Ensure product knowledge is integrated in the organization.
    • Ensure complaints are well managed, issues understood and trends in Global Medical Safety are understood.
    • Ensure Quality owners are involved in the escalations for all products in the portfolio.
  • Lead the preparation of the Product Indicators overview for Executive Management Review .
  • Serves as the single point of Global Quality contact for an assigned group of marketed products. 
  • Ensure end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release.
  • Know the product history and understand the processes across the various manufacturing sites.
  • Assure Quality milestones and Quality deliverables are achieved, and approves content of spec changes to ensure spec changes are aligned end-to-end.
  • Represent Global Quality on the Value Stream Teams (VST).
  • Support the business continuity process including VST strategy. Reviews Proactive Product Quality Scans with the VST and assures appropriate mitigating actions are defined there.
  • Ensure standard Global Quality processes (risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality.
  • Ensure complaints are well managed, issues are understood, and trends in Global Medical Safety, GMS are understood and addressed as necessary. Participate in product safety management teams.


Qualifications
  • A minimum of Bachelor’s degree (or equivalent degree) is required
  • A Master’s degree is desirable (pharmaceutical, chemical background or biological focus)
  • A minimum of 10 years’ experience in the Pharmaceutical, Biotechnology, OTC/Consumer, and/or Medical Device industry is required
  • Ability to make decisions on quality aspects of projects is required
  • In-depth knowledge in cGMP, standards, policies and procedures is required
  • Knowledge of Biotech and/or Pharmaceutical Manufacturing, particularly in technology transfer, is required
  • Knowledge of domestic and international GMP processes is preferred
  • Proven track record in leading multifunctional ‘virtual’ teams to success is a plus
  • Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering is required
  • Experience in Product & Process Development is a plus
  • Experience with Quality Systems is preferred
  • Experience with Quality content of Regulatory filings:  questions, and responses is preferred
  • Experience with regulatory inspections and preparedness is preferred
  • Ability to quickly assimilate new technologies, perform risk assessment and develop action plans is highly preferred
  • This position may require between 10-25% travel depending on business needs and will be located at one of the following sites: Cork, Ireland; Leiden, Netherland; Geel or Beerse, Belgium; Raritan, NJ; Springhouse or Malvern, PA; Schaffhausen, Switzerland or Latina, Italy 


Primary Location
United States-New Jersey-Raritan
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Geel, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality (Generalist)

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