Job Ref: 213169768

Date: 2021-02-11 14:25:36

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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

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