A large global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Global Director, Validation (Product Life Cycle Management) to work in Ware, UK - although this position can be based anywhere in Europe. This is an exciting opportunity to work at a top 10 global pharmaceutical company that employs approximately 100,000 people worldwide.
This Global Director, Validation role takes charge of Global Process Validation/Product Life Cycle Management and ensures they are in line with regulatory thinking, external best practice and are easily understood and practical.
- Responsible for defining GLOBAL Validation/PLM QMS Standards, ensuring these up to date with current and emerging regulatory requirements. Also advising key stakeholders on the potential impacts of new/emerging regulatory requirements.
- Responsible for benchmarking GLOBAL Validation / PLM standards against external industry. Ensuring that the Validation/PLM standard, tools and templates reflect industry best practices, are easy to interpret and are practical.
- Responsible for the governance framework for Process Validation / PLM in GLOBAL; forming and leading a cross-supply chain forum to maintain and govern the Validation/PLM standards, tools and templates.
- Ensuring appropriate governance in place to deploy consistent platform validation strategies across sites making the same product/family of products. Ensure PLM governance aligns with QC governance and with PQRM and Product Dashboard.
- Drive the development/application of a consistent training approach for Validation/PLM across GLOBAL.
- Responsible for ensuring appropriate training material, eLearning modules and training curricula available to supply chains /sites to support deployment of the validation/PLM standards, tools and templates.
- Ensure that training material focuses not only on regulatory requirements but also on identifying targeted PLM interventions to deliver business results.
- Responsible for ensuring standards allow for interaction between API drug substance, drug product, and/or devices e.g. in risk assessment standard etc.
- Lead global validation community of practice to progress adoption of best practices, and to share learnings from real-life examples across GLOBAL.
- Coach global teams as required in the development of complex validation plans involving multiple sites and formulations to ensure on quality/time/cost delivery of projects with significant contribution to business results (i.e. new product introduction, strategic tech transfer, material changes etc.)
Education and Experience:
- Bachelor’s degree in biological sciences, chemistry, engineering, pharmacy or related scientific discipline OR MSc or PhD
- Engineering or science particularly in areaofPharmaceuticals, Healthcare product development and production, with special emphasis on equipment, product and process understanding. Experience across multiple dose forms preferred.
- Previous experience of working with multidisciplinary teams, both at site and central levels.
- Proven capability of leading organisational change
- +15 years of experience in Pharmaceutical / Consumer Healthcare technical manufacturing or product development organisations.
- Practical experience in management and execution of process validation in pharmaceutical environment
- Knowledge of pharmaceutical manufacturing and development, working with a broad range of pharmaceutical dose forms and APIs Knowledge of drug product control strategies and unit operations across multiple dose forms
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.