QMS Leader

Role: QMS Leader

Location: Remote working (Amersham office)

Duration: 6 month maternity cover

Rate: Negotiable on experience (PAYE or Umbrella)

Our client is a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. They have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

We are looking for a QMS Leader to work with our expert QA team of over 250 employees across the world. Do you have a passion for Quality Management Systems? Then we would love to hear from you.

What you'll do

  • Provide comprehensive ownership of the Quality Management System (QMS) according to ISO 14385 and ISO 9001requirements.
  • Provide leadership and oversight to ensure Procedures, Work Instructions, and support tools such as Guidance Documents, Subject Matter Experts engagement, communication, training and effectiveness monitoring result in a robust, compliant and executable Quality System
  • Develop QMS relevant processes, improvement plans & lead efforts to reduce risk through evaluation of internal and external feedback
  • Ensure process efficiency and compliance effectiveness by working with documentation control and training teams
  • Support sites in maintaining QMS (adding/removing documents) while ensuring alignment with global procedures, and subject matter experts' recommendations
    Perform audits to monitor the effectiveness of QMS/processes at sites while ensuring independent audits or self-assessment on the global QMS processes/effectiveness are in place. Act on findings and recommendations. Drive execution rigor.

Who you are

  • Bachelor's Degree and minimum of 10 years working in a regulated medical device industry.
  • QMS 9001, 14385 or pharmaceutical(drug) QMS experience in the LiveScience medical device industry or pharmaceutical industry
  • Exceptional analytical, problem solving & root-cause analysis skills.
  • Excellent communication skills (written and oral)
  • Experienced in managing project teams and working cross - functionally and at global level
  • Demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls, verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management, services)

To apply please send your CV's in the first instance

  • Location

    Amersham, Buckinghamshire

  • Sector:

    Pharmaceuticals, Medical / Medicine, Audit

  • Job type:


  • Salary:

    £50 - £65 per hour

  • Contact:

    Ben McRae

  • Job ref:


  • Published:

    16 days ago

  • Duration:

    6 months

  • Expiry date:


  • Startdate:


  • Client:

    Jefferson Wells