GlaxoSmithKline Technical Manager - External Supply Pharma (2 Year Secondment / FTC) in United States
Technical Manager - External Supply Pharma (2 Year Secondment / FTC)
Open date:Oct 13, 2017 4:03 PM
Functional area:Supply Chain & Logistics
Barnard Castle,County Durham
Required degrees:Not Indicated
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Basic qualifications:• Degree in appropriate subject (Pharmacy, Chemistry, Engineering) and / or relevant industry experience within a similar role.
• A comprehensive background in Production/Technical Operational support covering multiple Dose-Forms and Technologies
• Experience of Issue Resolution (Troubleshoot, RCA, TRA)
• Demonstrable experience of New Product Introduction (NPI) within the pharmaceutical industry
• Experience of Product Transfer
• Operational Excellence experience
• Knowledge and experience of Change Control
• Demonstrated ability to work effectively in cross functional Team environment
Preferred qualifications:• Validation experience / knowledge is highly desirable
• Experience of Due Diligence
• Knowledge and experience of Supplier Qualification (Site Impact Assessment)
• Performance Management experience
• Knowledge and Experience of Quality Systems (QMS) within the pharmaceutical industry
• Customer complaint and Adverse Event Reporting experience is also highly desirable
• Regulatory dossier update experience
• Knowledge and experience of Product Release
• Integrated Sourcing Process and Contract Negotiation knowledge and experience is also desirable.
Details:We are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.
External Supply (ES) Technical is a support function to External Supply Pharma which part of GMS and is responsible for the management of Rx CMO’s Globally. (Approximately 110 CMOs Globally)
The Technical Manager is responsible and accountable for the provision of technical support to all manufacturing and packaging related processes (covering all dose forms) within External Supply Pharma.
To achieve this objective, the Technical Manager works with a multi-functional team of Procurement, Regulatory (incl. GPAR), Technical, Finance, Supply, Global Project SS and Quality professionals across the Global network.
Key Responsibilities / Deliverables:
• Supporting ongoing product supply from ES Pharma by ensuring robust and capable processes are in place and monitored.
• Technical-/trouble shooting-support to ES supply teams for ongoing manufacture packaging and supply of product from third party contractors.
• Technical process support for the introduction of New Products into new or existing Contract Manufacturing Organisations to ensure that they meet GSK requirements, are capable and robust, through close liaison and collaboration with R&D.
• Support of product transfers from GSK sites to a Contract Manufacturing Organisation, between Contract Manufacturing Organisations or from Contract Manufacturing Organisations to GSK sites, resulting from product / dose form source plans and strategic reviews.
• Owner of repository of knowledge and knowledge transfer associated with new and transferred products.
• Impact assessment and support of the process changes (GSK or Contract Manufacturing Organisation driven) related to active materials, excipients, primary and secondary packaging materials incl. risk assessment.
• Ensure with Quality Assurance, (ESQA) that necessary validation activities have been planned and executed to current standards (e.g. Product Lifecycle Management) in line with GSK QMS by Contract Manufacturing Organisations.
• Ensure that technical compliance gaps in manufacturing and packaging at Contract Manufacturing Organisations are highlighted and plans are developed to close the gaps.
• Technical project support related to all manufacturing/packaging related projects at Contract Manufacturing Organisations.
• Applying OE tools and principals in the implementation of technical projects and improvement initiatives.
• Support Due diligence activities by providing technical review and assessment of potential new products / CMO’s
Please note that this role can be based at any UK manufacturing site, we will also consider other sites within the European Manufacturing network. This role is a 2 year Secondment / FTC.
CLOSING DATE for applications: Friday 27th October (mid-day) 2017.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. We would also like to see your motivations and reasons for wanting to work within External Supply Technical.
The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
You may apply for this position online by selecting the Apply now button.
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