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Job

Senior Manager/ Associate Director Quality Assurance Validation

  • Location

    Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-10-31

  • Startdate:

    ASAP

Senior Manager/ Associate Director Quality Assurance Validation

In office in Lexington, MA

My client is a growing biopharmaceutical company located in Massachusetts looking to bring on an experienced QA professional into more of a leadership role. Our client has a vast pipeline with a focus on debilitating diseases.

If interested please apply directly to the role, or contact me directly at t.viola@hamlynwilliams.com

Responsibilities:

  • Serve as the process lead for quality management processes
  • Manage the sustainability of the GMP facilities, process and lab equipment design, qualification, and maintenance to include, but not limited to, QA Oversight of Implementation, Qualification, Preventative Maintenance, Calibration, Requalification and Periodic Review
  • Support the QMS, lead a process workstream designed to monitor and improve said process(es) within the GxP QMS framework
  • Work effectively across the matrix by engaging with the broader process owner network and site or function process owners in designing and deploying systems
  • Identify and track progress against key project milestones partnering with applicable business process, equipment, and facilities owners along with any external providers to ensure overall project success and compliance
  • Work closely with the BPO’s to ensure Periodic reviews are completed in a timely manner to demonstrate systems have remained in a controlled, validated state and are fit for use

Qualifications

  • 6+ years’ industrial experience with 2+ years’ in a regulated environment
  • Knowledge of Quality compliance processes and regulations (e.g. GLP, GMP, GCP)
  • Familiar with electronic quality system tools (e.g. Veeva Vault)
  • Strong program and project management experience
  • Proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects, in Quality
  • Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities
  • Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities

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