• Quality Program Manager, Sterility Assurance

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1466
    Category
    Quality Control
  • Overview

    The Quality Program Manager, Sterility Assurance is responsible for planning, coordinating and facilitating microbial control activities required for Dendreon’s drug products. The role will interact with all site and cross site functions that could impact Dendreon's microbial control program including Facilities, QC Microbiology, Manufacturing, Process Sciences.

    Responsibilities

    • Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
    • Partner with Manufacturing to champion company’s compliance to aseptic procedures and practices in accordance with current regulatory requirements and industry guidance.
    • Engage directly with site personnel to promote an aseptic operations culture and to provide aseptic subject matter expert knowledge.
    • Provide microbiological support to the internal audit and inspection readiness programs
    • Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
    • Support resolution of problems, identify trends and determine system improvements.
    • Must be familiar with implementation of microbiological environmental monitoring programs and must understand interpretation of microbiological data including evaluation of trends.
    • Provide microbiological evaluation of site change controls.
    • Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, protocols, reports and deviations/investigations.
    • Communicate updates, metrics and outstanding items to senior personnel as required.
    • Provide assurance of consistent aseptic programs and initiatives across multiple sites.
    • Mentors and develops Quality and Operations department staff.
    • Perform additional tasks as directed by senior management.

    Qualifications

    • Requires MS degree in Life Sciences or related field and at least 8 years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections.
    • Minimum of 7 years’ experience working in a GMP regulated environment.
    • Extensive knowledge regarding aseptic operations.
    • Proven ability to formulate a compelling vision and develop a strategy with key stakeholders to achieve that vision.
    • History of building and maintaining positive relationships both internally and externally.
    • Proven ability to influence and motivate cross-functional teams.
    • Strong communicator with excellent verbal, written and presentation skills.
    • Can negotiate skillfully in tough situations with both internal and external groups

     

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