LOC Quality Manager

Job Description

Site Name: Pakistan - Sindh - Karachi Posted Date: Sep 15 2022 Job Purpose The job exists within the commercial Rx Local Operating Companies to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met. The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected to take the lead in implementing and sustaining the QMS for GSK LOC, including encouraging the Commercial Rx business to own quality activities in their day-to-day work. Experience, Education & Skills B Pharmacy or Pharm D Degree Minimum of 5-8 years? experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager Good team player ? works well in cross-functional teams People management and development skills Good time management skills, with ability to multi-task and work under pressure Key Responsibilities Key market contact and responsible person for all QMS activity and issues, relating to the commercial business. Assess and proactively create and implement a continuous improvement plan for the adoption of the principles and requirements of a Quality Management System into the commercial business, includes identifying, understanding and sharing appropriate information. Heighten and promote quality and QMS awareness in the commercial business functions. Engage and assist relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business, in compliance with QMS principles. Build strong relationships across the LOC Commercial Business functions and work with them to develop quality objectives that meet both business and regional quality objectives. Undertake relevant training forums to deliver QMS knowledge to relevant parts of the business enabling them to identify, incorporate and deliver on relevant quality objectives. Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity. Develop a network to obtain local regulatory intelligence and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK?s reputation. Act as the relevant LOC quality contact for the Regional Quality organization providing communication to the regional quality organization on progress on QMS compliance status updates on quality plans and escalation of issues. Share learning?s and issues appropriately with other LOC and regional colleagues. Gain understanding of the high-level business plans of the LOC as they potentially link to quality ensure any quality activities are identified and defined in the annual quality plan. Responsible for ensuring a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within GSK LOC/Marketing Company. Implementation and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP. Ensure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system is in place for tracking training compliance and process for escalation of persistent non-compliance. Processes are in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant. Risk Management - Local risk management process in place across business with common review and escalation process. Local process in place to manage, report, review and escalate quality risks. Quality should be linked to the local Risk Management Board. GSK is a global biopharma company with a special purpose ? to unite science, technology and talent to get ahead of disease together ? so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns ? as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it?s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We?re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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