Director Compliance, Risk Management and Labelling
Posted on Dec 9, 2018 by GlaxoSmithKline
In this role, you will ensure that the Consumer Healthcare Global Regulatory Affairs function has a comprehensive, embedded, integrated Compliance and Risk Management program that delivers quality, compliance and continuous improvement for regulatory activities and processes. In collaboration with the other business units, you will facilitate the development and delivery of the overall Global Regulatory Affairs quality and compliance strategy.
You will be accountable for the CH GRA labelling processes, run the Global Regulatory Oversight Committee and lead interaction with Audit and Assurance.
The interfaces include the R&D Compliance Officer, Lead of R&D Strategic Risk, Regulatory Governance Board and the global cross functional network of Quality/Compliance/Risk Management leaders, to deliver an effective integrated compliance program within GRA.
Your role oversees the operational support for compliance activities (e.g. documentation management (SOP, WI, etc), training management, audit support and follow-up of related CAPAs) within Central Regulatory Affairs, continuously supporting strategies and plans to ensure regulatory strategic risks related to process are identified, managed and mitigated/prevented.
You are also accountable for ensuring written processes and procedures (e.g. SOPs, WIs, etc) are in place within Central Regulatory Affairs with associated training plans, training tracking, internal assessment (Management Monitoring) and KPIs aligned to GSK CH and GSK Enterprise policies.
In addition you will be the interface for audits and external inspections that impact the Central Regulatory team, and drives on-time completion of the related CAPAs.
You will provide oversight and awareness of local internal/external regulatory audits to ensure learnings are captured and processes/systems updated in line with CAPAs/recommendations.
Why You?Basic qualifications:
• 7+ years' experience in a Regulatory Affairs/Quality area with extensive understanding of the regulated environment, compliance expectations, processes across the portfolio (drugs, devices, supplements, cosmetics)
• 3-5 years within consumer healthcare or pharmaceutical company
• University degree in Life science (Chemistry, Pharmacy, Biochemistry, Biology), with a specialization in Regulatory Affairs, Quality Assurance, Pharmacy
• Fluent English (oral and writting)
• A proven track record of successful Regulatory inspections (internal/external)
• Practical experience leading and implementing process improvement activities, embed quality and continuous improvement
• Proven experience in at least 2 of the following is mandatory : Compliance, Risk Management and Labelling
Specialized education : Qualified Person (QP) or PhD/PharmD
GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Our Consumer Healthcare business develops and markets products in Wellness, Oral health, Nutrition and Skin health categories. Our seven global power brands - Otrivin, Panadol, parodontax, Poligrip, Sensodyne, Theraflu and Voltaren, include some of the most trusted and best-selling brands in the world.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employee.
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