Quality R&D Manager Product Optimization
- GlaxoSmithKline Plc Switzerland
- Vaud (La Côte)
- Date de publication
GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of pharmaceuticals, vaccines and consumer healthcare.
As one of the few healthcare companies researching both medicines and vaccines for the World Health Organization’s three priority diseases – HIV/AIDS, tuberculosis and malaria, we are very proud to have developed some of the leading global medicines in these fields.
Regarding GSK Consumer Healthcare we are one of the world’s leading over-the-counter (OTC) medicines company. We hold number one positions in OTC medicines across 36 markets, and are market leaders in specialist oral care.
We have a portfolio of loved and trusted brands that are underpinned by science including: Sensodyne, Parodontax, Poligrip, Voltaren, Panadol, Otrivin and Theraflu.
In 2015, the Consumer Healthcare business accounted for £6.0 billion, or 25%, of total Group turnover.
Quality R&D Manager Product Optimization
As a Quality R&D Manager Product Optimization you will be responsible for managing the overall Quality and Compliance activities during the product development & optimisation life cycle end to end processes and to ensure adherence to market(s) Health Authority regulatory requirements as well as GSK Standards.
You will also lead Quality for the Product Optimization projects and be the single point of contact for Quality during the development, transfer, and launch of the products. This role is a core team member and performs the R&D Quality activities in support of the research activities.
Your responsibilities include in detail:
• Lead the Quality / Compliance activities for assigned product optimization for maintenance of marketed products projects and new product launches. Lead Quality during the development and product transfer from R&D to internal/external sites.
• Core Team Member of product optimization Projects and Quality liaison for Project from inception through launch. Accountable to ensure all functional Quality support is provided to the Project.
• Quality representative on Optimization Technical Review Committees and Councils with decision rights on the projects.
• Review and approve CMC and non CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and calibration related documents, process and product transfer protocol and reports and packaging documentation.
• Lead and oversee Change Control, Deviation, and CAPAs for R&D projects.
• Support clinical supplies activities, including providing formal approval and release proposal for clinical supplies, registration samples and consumer test supplies.
• Quality oversight of Pilot, Lab, and Clinical Supply facilities, including compliance responsibilities.
• Manage Heath Authorities and internal audits at local R&D sites and follow up on the appropriateness and completeness of corrective action plans.
• Support and/or lead GMP training program for R&D and ensure training practices are in compliance with the current standards.
As a successful Quality R&D Manager Product Optimization, you have excellent organization and communication skills. You are recognized for your patience, your drive and for being details oriented. You are also comfortable to navigate into a challenging and changing work environment.
Furthermore you display the following qualifications and competencies:
• Advanced degree in Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Minimum 10 years’ experience in the pharmaceutical industry related to Quality Assurance, Drug Regulatory Affairs, Technical Operations, or Drug Development in a GMP environment
• Understanding of product technical specifications and processes utilized in product development and industrialization of new drug products.
• Advanced level of understanding product characteristics and clinical / development processes.
• Knowledge of manufacturing, packaging, clinical labeling, and analytical testing requirements to gain sufficient understanding of complexities in each area and the interdependencies between them.
• Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines
• Experience working in global and multidisciplinary environments
• Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
• Good level of coordination and communication
• Fluent in English and French