Current Job Openings

Quality Management System (QMS) Manager

Role Description

The QMS manager role is a key part of the global quality organization, in establishing and driving a culture of Quality and compliance within TPG. With accountability for the implementation, development, expansion and improvement of the global Quality Management System within which the various TPG GXP business functions operate, this role is fundamental to the expansion and growth of the business, in line with regulatory expectations whilst minimizing risk to product quality and patient safety.

Expected responsibilities for the QMS Manager are:

  • Quality management system oversight
  • Maintain, develop and improve the core QMS processes / procedures for:
    • Deviation Management
    • Change Control / Management
    • CAPAs
    • Qualification and Validation
    • Risk Management and the Quality Risk Register
    • Product Quality Complaint Management
    • Product Recall
    • Document Management and Control
    • Quality Management Review
  • Manage and monitor the throughput of data and information through each of these core QMS processes,
    identifying and generating appropriate metrics from each system, and communicating those metrics to
    functions and as part of the wider management review activities (see below).
  • Develop Key Performance Indicators for the core QMS elements that give a real time indication of
    the overall performance of the QMS and its status of control.
  • Maintain the quality risk register ensuring that all quality risks identified within the business are actively managed and mitigated as per agreed actions and to suitable levels.
  • Maintain and deliver core processes for:
    • Quality Management Review – Ensure Quality Management Review is delivered locally and globally as
      per defined timelines and that each level of management review is supported with the provision of QMS
      data and metrics.
    • GXP Training – Maintain and deliver the process for scheduling, delivery and recording of training
      for all TPG employees working within the GXP environments. Generate metrics on training
      compliance, and evaluate the needs for establishing effective means for determining training
      effectiveness.
    • Site Master Files and Quality Manuals – Maintain core documents such as Site Master Files and
      Quality Manuals (and others). Ensure periodic review and necessary updates to the documents so they
      always remain current and audit / inspection ready.
    • Product Quality / Customer Complaints – Maintain and develop the process for Product Quality and
      Customer complaints, and be the key contributor to the review, evaluation investigation and response
      to individual complaint records received.
  • Identity needs for and as necessary write new standard operating procedures (SOPs) within the Quality Function.
  • Support other operational functions in the creation and drafting of operational SOPs that impact GXP operations,
  • Drive the need for timely review and update of existing SOPs
  • Maintain and govern the electronic QMS (eQMS) and document management system for SOPs including
    requirements for qualification and validation
  • Updates of the system.
  • Support with the assessment of any technology required to enhance the capabilities and efficient of
    the Quality Assurance function
  • Support the Business Management function with Quality Assurance related training activities
    Work cross-functionally within Tanner Pharma to support other divisions as needed

Desired Candidate Profile & Capabilities

  • Minimum of 5 years of professional experience in the pharmaceutical industry in a Quality Assurance
    role either with a service provider or manufacturer
  • Strong understanding of requirements relating to GMP and GDP; Practical knowledge of both preferred.
  • Significant past experience managing a QMS in a pharmaceutical or healthcare environment is essential
  • Highly organized and process oriented
  • Detail oriented with experience ensuring documentation is completed correctly and according to a
    defined process
  • Capable of multi-tasking and managing multiple priorities
  • Ability to see tasks through to completion efficiently and pragmatically
  • Comfort and experience working in a high-paced and high-workload environment
  • Self-motivated with a passion for learning and ability to recognize when something needs to be done
    and without needing to be told what to do
  • A can-do attitude with a willingness to expand capabilities beyond the comfort zone
  • Willingness to roll up the sleeves to get the job done, but ability to think strategically and
    interact comfortably with senior executives

Compensation & Benefits

  • Salary commensurate with experience
  • Pension scheme
  • Private health insurance
  • Attractive performance incentive plan with profit sharing
  • Vacation and paid sick leave

    • Tanner Pharma Group is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

      Additionally, Drug and background screening will be required for employment.

      Job Type: Full-time

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