• Manager, Supplier Quality

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1246
    Category
    Quality Control
  • Overview

    The Manager, Supplier Quality is responsible for managing  the operations in one or more functional areas within Supplier Quality including planning of Raw Material Release, Resource Management, External Suppliers, and Contract Laboratory oversight.

    Responsibilities

    Responsibilities:

    • Responsible for Management of the following:
    • Supplier Quality raw material primary contact and process owner
    • Raw materials inspection and release approver
    • Raw materials non-conformance and supplier investigations
    • Qualification and approver of new suppliers and raw materials
    • Coordination of activities with external laboratories contracted to conduct development or sample testing of raw materials
    • Ensures raw materials conform to company standards and satisfy GMP regulations
    • Reviews and approves change controls, methods, procedures for inspecting, testing, sampling plans and evaluating the quality of raw materials and contract laboratories.
    • Investigates non-conforming material defects and contract laboratory OOS results, provides feedback to suppliers, and approves corrective actions to be taken ensuring conformity with quality specifications.
    • Provides technical insight to other departments as part of cross-functional project teams.
    • Monitor GMP Supplier Quality systems to ensure compliance with documented policies
    • Ability to train, develop and mentor direct reports and effectively manage the performance of individuals in multiple locations.
    • Contributes to the development of department budget and monitors expenditures.

     

    Scope:

     

    • Receives assignments in the form of objectives and establishes goals. Provides guidance to direct staff members to achieve goals in accordance with established policies. Assignments are reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies affecting Supplier Quality Raw Materials.
    • Provides leadership with regards to problems of diverse scope where analysis of the situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as leader to staff to meet schedules and/or resolve technical problems. Develops and administers schedules and performance requirements.
    • Frequently interacts with direct reports, customers and/or functional peer group managers. Interacts with senior management, interactions normally involve matters between functional areas, and external suppliers.
    • Job Requirements: Manages activities related to monthly QPI, defect tracking, costs, and on time raw material release. May be responsible for a functional area and may not have subordinate supervisors or employees, or may manage highly skilled professional employees.

     

     

    Qualifications

    • Bachelor's degree in a scientific discipline or equivalent.
    • Typically 7 years related experience in cGMP/FDA regulated industry.
    • Typically 3 years leadership experience.
    • Knowledge of cGMP/ICH/FDA/USP/ASTM regulations and standards.
    • Knowledge of lean six sigma and/or statistical techniques
    • Experience in conducting investigations, implementing CAPAs, initiating change controls and auditing
    • Ability to think critically and creatively to identify and solve problems
    • Familiarity with technology transfer, BLA
    • Proficient in MS Office applications.

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