Valeant Pharmaceuticals

  • Senior Quality Engineer (Compliance Specialist)

    Job Location US-NJ-Bridgewater
    Job ID
    10835
    Pos. 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 Senior External Manufacturing Quality Specialist will support compliant execution of quality-related activities, including but not limited to, new quality system/methodologies implementation, training, CAPA, change management, problem solving, product and process development, acceptance activities.

     

    This position will also work directly with Valeant Finished Good (FG)/External Manufacturing (EM) suppliers, as well as medical device/Pharmaceutical product manufacturing facilities, to provide sustaining quality and compliance leadership and routine support related to current commercialized products

     

    In addition the position is responsible for developing Product Annual Reports and measure, and report key quality metrics to drive quality and efficiency.

     

    The scope of this position is directly related to the Bridgewater NJ External Manufacturing.

     

    The position has no supervisory responsibilities.

     

    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 control systems at the Medical Device/Pharma/EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
    • Collaborate and support companywide quality planning continuous improvement projects (e.g. QSIP etc.)
    • Ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Valeant requirements
    • Support North America supplier management team in identifying opportunities for improvements.
    • Complete Non-conformances and CAPAs related to FG/EM suppliers within required timelines.
    • Proactively investigate, identify and implement best-in-class Supplier Quality practices.
    • Provide technical mentorship and resolve quality supply chain issues with Valeant and FG/EM suppliers.
    • Support quality disciplines, decisions, and practices across Bridgewater, NJ site.
    • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers.
    • Assist EM QA functions, supply chain and R&D organizations in sourcing new FG/EM suppliers.
    • Participate in quality change request management activities, corrective and preventive actions as well as effectiveness verification activities, as required.
    • Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies) that occur at the BW site
    • Directly support management team for activities related to Annual Product Reviews, Management Review, Complaint Review Board and Critical Action Committee
    • Key Relationships: 

      Internal Customers/Business Partners:

       

      Regulatory Affairs (NA)
      Research and Development
      Global Product Surveillance and Safety
      Quality Assurance
      Compliance Senior Leadership Bridgewater, NJ

       

      External Customers and Business Partners:

       

      Finished Goods / External Manufacturing Suppliers
      Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

       

    Qualifications

    • Bachelor of Science degree in an engineering discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc) is required.
    • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/QE)
    • 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 6 years within a supplier quality organization (minimum 4 years in the Medical Device or Pharmaceutical industry is required).
    • A Master’s degree in an engineering or technical related discipline may be substituted for two years of experience.
    • 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 210, 211, 820, ISO 13485, ISO 14971.
    • 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.
    • Experience in electronic quality system modules such as ComplianceWire, CATSWeb, Documentum, QlickView etc.
    • 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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