QA Compliance Section Head

Site Name: Egypt - Cairo Posted Date: Dec 1 2022 Are you a QA Compliance Section Head who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this role is the one for you to explore. As a QA Compliance Section Head, you will be the Process Owner for Effective Implementation of QMS, QMS Structure, Content, Management and Deployment. Be the process Owner of CAPA system, CCR System, closure on VQMS. Responsible for enhancing the management process to meet company business objectives through Managing QMS implementation on site and ensuring QMS is in place and in use, and Handling internal and external Audits. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Lead QMS implementation within the site to ensure that all QMS documents are assessed regarding QMS applicability and deployment. Lead assessment of on-going effectiveness of local QMS Implementation Support the implementation and maintenance of effective quality assurance systems to ensure that quality related operations are in full compliance with GSK standards and policies. Follow up quality KPIs, ensure quality targets are met. Support cross functional teams in QMS gap analysis through liaison with QMS Process Owners and QMS Reviewers. Act as site inspection readiness lead for hosting customer, regulatory audits, and support site readiness to pre-inspection/ regular GMP audits through implementing extensive program including quality oversight GEMBA and in use verification of critical policies, identify and co-ordinate the activities and resources to prepare for the inspection of the site and communicate inspection readiness status to local and regional stakeholders. Conduct internal audit runs as lead auditor and support other lead auditors in the site and ensure adherence to internal audit schedule and the completion of audit cycle in specific timelines. Ensure the deployment of audit universe with risk-based approach against quality management system requirements and create site internal audit schedule that include all GMP activities in the site with different audit types. Revise and monitor site internal KPIs and report monthly progress to site quality council. Responsible on the Quality Agreements between Service providers and Third-party customers. Manage the Changes across the site and follow up on the change actions. Handle the Quality system forums across the site and systems review on VQMS Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree of Pharmacy, Science, Chemistry or equivalent. Minimum 3 – 5 Years of experience in similar role. Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System. Excellent documentation and report writing skills. Excellent verbal and written communication skills. Familiar with facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities. Good command of English and computer skills. Self-motivation, empowerment and adaptation to business changes. Strong prioritization and organization skills. Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. 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 GSK's 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. 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