Quality Assurance Manager - Groton, United States - Rangam

    Rangam
    Rangam Groton, United States

    3 weeks ago

    Default job background
    Description

    Pay Scale: $47.00 -$48.00 per Hourly

    Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.

    Job Description:

    Hybrid: Required Onsite 2-3 days per weeks, will need to be local to the Groton Site.

    Support US and UK time zones.

    Strictly GMPs for this role, not GCP

    Hard Skills:

    • Vendor Quality Management Exp. in Pharma industry
    • cGMP, not GCP
    • Project management
    • MS Office

    Plus Skill:

    • Relationship building
    • Negotiation
    • Auditing
    • SAP

    BS Preferred

    (open to 5 + years' experience in lieu of degree)

    • You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors.
    • You will be the Vendor Point of Contact responsible for the quality management of approximately 25 contract manufacturers, packager, contract test laboratories, and supply partners globally.
    • As a Quality Manager, you will focus on developing relationships, independently negotiating, developing and communicating Client quality requirements with contract vendors.
    • Your expertise provides quality system leadership to operational teams, drive process improvement, advancing new concepts and methodologies that will make Client ready to achieve new milestones and help patients worldwide.
    • Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
    • Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people.
    • Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and Client expectations.
    • Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate.
    • Provides project support with current Good Manufacturing Practices to clinical supply packaging operations.
    • Provides guidance on procedures and training necessary to be in complete compliance with current GMPs.