Bausch Health

  • Sr Manager, Quality Systems - External Manufacturing

    Location US-NJ-Bridgewater
    Job ID
    12190
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Oversees parts of the pharmaceutical regulated quality system related to CAPA, nonconformance, document & records management, and change management to ensure compliance and resolution of issues

     

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

    The position has supervisory responsibilities for a team of 4-8 quality professionals.

    Responsibilities

    KEY ACTIVITIES/
    RESPONSIBILITIES

    Leads the external manufacturing quality operations team.  This team is responsible for managing a network of external manufacturers supplying drugs, devices, biologics, cosmetics, and nutritional products to the US. 

     

    The quality operations team is the main interface with the external manufacturers.  This team is responsible for product release, deviations/nonconformances, change controls, and other quality activities to ensure product is delivered to our customers in a high quality, timely manner. 

     

    This position is responsible for:

    ·         Provide effective leadership in supporting quality disciplines, decisions, and practices for the external manufacturing quality team.

    ·         Ensure the timely delivering of product to our distribution centers. 

    ·         Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

    ·         In conjunction with supply chain, work to resolve challenges with external manufacturers.

    ·         Develop, measure, and report key quality metrics to drive quality and efficiency.

    ·         Proactively investigate, identify and implement best-in-class quality practices. 

    ·         Establish process model for quality improvement and provides training to organization personnel.

    ·         Mentor and lead quality professionals within the team to promote growth and development.

    • Inform senior management on an ongoing basis about the performance of our external manufacturing network.
    • Support external and internal audit as SME for quality operations. 

    SUPERVISE DIRECT REPORTS

    (yes or no)

    Yes

    SCOPE OF POSITION – e.g.

    Sales volume responsibility

    Budget responsibility

    Size of Team

    Sites

    (GENERAL INFORMATION FOR THE POSITION)

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

     

    The position has supervisory responsibilities for a team of 4-8 direct reports with a team of 12 – 18 quality professionals.

    KEY RELATIONSHIPS

    (e.g. internal customers/business partners, external customers/partners)

    Internal Customers/Business Partners:

    Regulatory Affairs (NA)

    Research and Development

    Quality Assurance &Compliance Senior Leadership (NA)

    Supply Chain

    Technical Operations

     

    External Customers and Business Partners:

    -          Finished Goods / External Manufacturing Suppliers

    -          Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

    Qualifications

    QUALIFICATIONS/
    TRAINING

    (e.g. professional qualifications, on-the-job training, education)

    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 by 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.

     

    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, 600, 606, and 820; ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations.

     

    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.

    EXPERIENCE

    (e.g. health care industry, multinational company, number of years, what level/types of roles, etc)

     

    A minimum of 10 years within a quality organization (minimum 4 years in the Medical Device or Pharmaceutical industry is required).

     

    3-5 years’ experience supervising professional level employees.    

     

    Lean six sigma experience highly preferred

     

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