Validation / Product Lifecycle Management Leader, GMS
What level of education do I need to apply?
You will hold a Bachelors degree in biological sciences, chemistry, engineering, pharmacy or related scientific discipline.
What experience do I need?
You will have a well established background in Pharmaceutical / Consumer Healthcare technical manufacturing or product development organizations.
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
Competent in the following processes- Technical Risk Assessment(TRA), Continued Process Verification (CPV), Periodic Process Review (PPR), Statistical sampling, Statistical Process Control etc.
Extensive knowledge of cGMPs, FDA and international guidelines dealing with validation, pharmaceutical manufacturing and quality assurance.
Deep understanding of practicalities of implementing Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10, and Product Lifecycle Management
Understanding the differing regulatory views on QbD across various regulatory authorities around the world, and the impact this has on regulatory strategy and submissions.
Knowledge of GSK PPD road-map and roles for chemical and product development.
Demonstrated ability to lead and prioritize multiple activities / programs of work.
Demonstrated self starter with strong self management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization.
This role can be based in the UK, Ireland or the US but you must have the right to work.
What other experience would benefit this role?
Previous experience of working with multidisciplinary teams, both at site and central levels.
Direct line and matrix management experience
Proven capability of leading organisational change
Capable and confident to interface with senior stakeholders
Specific quality and compliance expertise in one or more dose forms (including API and secondary manufacturing)
What is the purpose of this role?
This is a brand new role to GSK with the flexibility to be located in the UK, Ireland or the US.
As the Validation / Product Lifecycle Management Leader you will be accountable for process and cleaning validation standards across GMS.
This role will be accountable for process and cleaning validation standards across GMS.
The role will work in Matrix environment and run a Validation Core Team to govern and maintain these standards, with representation from each of the Global Pharma Supply Sites, the Consumer healthcare SC and the Regional Pharma SC.
As the Validation / Product Lifecycle Management Lead you will own GMS Process Validation / PLM standards, ensuring they reflect current Regulatory thinking, are benchmarked against external best practice, are easily understood and are practical.
You will own the Validation/PLM governance framework to maintain the GMS Process Validation / PLM standards, and also ensure standard validation strategies deployed across sites making same products.
You will ensure appropriate training material available to facilitate deployment of Validation/PLM standards consistently across sites/supply chains. Also competency framework to confirm capability at sites.
You will lead Community of Practice to facilitate best practice sharing, knowledge sharing and learnings.
What are the key responsibilities?
- Responsible for defining GMS 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 GMS 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 GMS ; forming and leading a cross supply chain forum to maintain and govern the Validation/PLM standards, tools and templates. Also 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 GMS. Responsible for ensuring appropriate training material , e-learning 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 competency framework in place to confirm site technical and quality staff accountable for PPR, CPV, PLM have the appropriate capabilities. (TRA L1/L2 ; statistical understanding etc.)
- 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 GMS.
- 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.)
- Primary GMS partner with R&D to define knowledge transfer for Process Validation and Continued Process Verification stages of Product Lifecycle
How do I apply?
Closing date for applications: 6 Sept 2017
When applying for this role, please ensure you use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
If requiring an adjustment for a disability, once selected for interview you may contact: [email protected]
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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