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QA Manager

Central London   •  Negotiable  •  Permanent, Full time

We are proud to be partnered with one of the worlds leading Pharmaceutical companies. They are seeking a Quality Assurance Manager within their Diagnostics division - a great opportunity for someone with extensive experience within this sector of life sciences!

This is a role to look after the UK, Ireland and Nordics covering the below skillset;

  1. Primary Objective of Position

    • Ensure Quality System awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility.
    • Supports the business in the affiliate/ region according to the position expertise and functions.

  1. Major Accountabilities

this can be Inclusive of

    • Plan and conduct internal audits to verify the effectiveness of the management system
    • Prepare/ coordinate external audits.
    • Perform supplier audits as required.
    • Support/provide training to the organization about the ADD Quality System.
    • Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and ensure timely closure.
    • Coordinate Field Communications at the Region.
    • Ensure availability of org charts (including LSME if required) and job descriptions.
    • Ensure the setting and tracking of the Training Plan for all positions.
    • Assess risk related to processes
    • Timely escalate regional concerns to Area Management Review and MIMS MR
    • Supports Global Commercial Affiliates QA improvement projects
    • Maintain/ challenge current certifications. Propose new certificates if required.
    • Coordinates communication between commercial organization and Regulatory to support responses in contracts and public tenders (QARA, EHS requirements). ·
    • Team/ MIMS Subject Matter Expert & Procedure Owner: Be the expert on a QS process and support the rest of team as process SME: either as lead, backup or team member.
    • Review company policies & procedures, and update Quality documentation accordingly.
    • Manage any audit input by initiating changes to affected processes following MIMS change control procedures.
    • Identify and coordinate improvement initiatives within the entire QS.
    • Participates in Quality System improvements and implementation projects
    • Actively seek internal/external customer feedback and respond to issues
    • If there is no regulatory function in the affiliate, perform/ ensure revision and approval of locally/translated AdPromo material on behalf of Regulatory Affairs. If needed, support RA appointing language approvers and ensure trainings are done accordingly
    • Manage the QA budget, always considering cost improvement opportunities

Manager Quality only:

    • Act as an expert for sales and customer support for accreditation topics, presentations and process implementation in sites where customer certification I accreditation is requested

Senior Manager Quality main accountability:

    • Ensure that knowledge and experience acquired during their professional life is transferred to other team members.
    • Mentor and develop other Quality Managers

  • Agency: Cpl Life Sciences
  • Contact: Sheldon Grant
  • Reference: JO-2105-469574
  • Posted: 1st June 2021
  • Expires: 29th June 2021

Cpl Life Sciences

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