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