Valeant Pharmaceuticals

  • Quality Engineer (Compliance Specialist)

    Location US-NJ-Bridgewater
    Job ID
    10378
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    The  Supplier Quality Engineer-External Manufacturing will work directly with Valeant/Bausch + Lomb  External Manufacturing (EM) suppliers, to provide sustaining quality leadership and routine support related to current commercialized product as well as newly developed products.

     

    In addition, the position will ensure finished EM suppliers are compliant to all regulatory (US and International) and Valeant/B+L requirements.

     

    The scope of this position is directly related to the External Manufacturing Supplier Quality Organization.

     

    The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory and Commercial) and external business partners (External Manufacturing groups).

    Responsibilities

    • Identify and implement effective quality systems at the finished EM supplier sites to support the development, qualification, and on-going manufacturing of EM  products to meet or exceed internal and external requirements.
    • Support USA supplier management team in identifying opportunities for improvements.
    • Complete Batch Releases, Non-conformances, Quality Change Requests and CAPAs including root cause investigations related to EM suppliers within required timelines.
    • Proactively investigate, identify and implement best-in-class Quality practices.
    • Escalate quality supply chain issues with Valeant/ B+L  EM suppliers to Senior Quality Management.
    • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with EM suppliers.
    • Track and Trend all quality inputs (Complaints, Non-conformances, CAPAs, root cause, change management) and identify adverse trends and institute corrective and preventive actions and effectiveness verifications.
    • Directly support management team for activities related to Management Review, Complaint Review Board, Material Review Board, Local Change Board and Critical Action Committee.
      • Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
    • Key Relationships: 
      Internal Customers/Business Partners:
      Regulatory Affairs
      Research and Development
      Global Product Surveillance and Safety, Pharmacovigilance
      Design Quality Assurance
      Compliance Senior Leadership
      External Customers and Business Partners:
      Finished RX, OTC, Cosmetic and Medical Device EM Suppliers
      Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

       

    Qualifications

    • Bachelor of Science degree in a technical discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc.) is required.
    • Experience with Root Cause Analysis and Technical Writing in FDA regulated environment is required.
    • Excellent communication skills (verbal and written).
    • Ability to successfully influence others within project teams regarding quality or compliance concerns.
    • Excellent organizations and presentation skills.
    • Ability to hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions and performing effective verification activities.
    • A minimum of 2 years related Quality Engineering experience (Medical Device or Pharmaceutical industry is required).
    • Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls.
    • Ability to travel to supplier sites is required.
    • Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
    • Familiar with 21 CFR Part 111, 210, 211 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations, ICH Q7A.
    • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and ability to mentor stakeholders in analysis of process data and metrics to identify root cause of complex problems and development and implementation of preventative or corrective actions.
    • Expertise in providing creative solutions to complex issues.

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

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