Quality Compliance Section Head

Job Description

Site Name: Egypt - Giza - Giza Posted Date: Apr 26 2022 Are you a leader by nature? Are you a Quality Systems expert who is energized by the idea of playing a key role within the Quality Compliance team in on of the leading pharmaceutical companies worldwide? If so, then this Quality Compliance Section Head opportunity is the one for you to explore. As a Quality Compliance Section Head, you will provide leadership within the Quality Systems functional area, focusing on building and strengthening deployment of QMS, CCR, Quality alerts, CAPA. You will lead internal/external audits, host and reply to toll manufacturers, regulatory audits and audit and assurance. You will enhance management processes to meet company business objectives through Managing QMS implementation on site and ensuring QMS is in place and in use. You will be the process owner for the effective implementation of QMS, QMS Structure, Content, Management, Auditing, CAPA, CCR systems and Deployment. You will act as the QMS Champion across all site operations and as a point of contact to provide support/training/coaching for QMS Process Owners and QMS Reviewers. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Auditing system: Internal audit and self-inspection Process Manager. Ensures the deployment of audit universe with risk-based approach against QMS requirements. Support suppliers and TPM audits. CAPA Management: Act as site system Lead for Trackwise software for CAPA Management. Ensure effective CAPA closure in timely manner to maintain monthly green dashboard. Implement CAPA effectiveness program and sustain deliverables. Regulatory inspection and compliance: Act as Site inspection readiness Lead hosting audits. Handle and manage site quality issues related to site quality compliance performance. Monitor site readiness for inspection. Ensure local and global regulatory conformance and alignment. QMS Implementation: Lead GSK-QMS policies and PGSOPs deployment and assure their effective implementation. Follow up of key policies handling (Deviation handling, customer complaints, Recall, Sterile operations, risk management, document and data management & control change and validation). Participate in annual Quality strategy and objectives (QIP). Provide oversight and governance to ensure quality standards are effectively implemented in manufacturing sites across the GSK Network. Respond to Quality Alerts and QRI and ensure prevention of its occurrence in site by implementation of recommended action plans Document management and control: Ensure proper lifecycle management of documents through Veeva. Change control: Act as change control Process Owner for the planned changes and review their effective implementation. Manage and lead all projects related to all change initiatives e.g. commercial, R&D, Technical and supply. Follow up for delivery and completion of agreed actions and resourced projects within quality parameters. Escalate deviations from the plan Perform annual review for changes implementation performance and adherence. Quality risk model champion for the site to manage local and regional communications for the site model Prepare and approve quality improvement plan and ensure implementation of the plans Prepare the site master file to be ready for regulatory and customer inspections Manage customers quality agreement and TTS Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in Pharmaceutical sciences 4-5 years of experience within the pharmaceutical field Quality systems background Strong leadership skills Learning agility Good communication skills Multitasking 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. 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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