Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our We Are Sanofi movie As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. Discover what it means to work in Sanofi via this video Core responsibilities Accountable for all quality system and implementation overall site Create a positive quality culture and quality mindset Leading and coaching of site and quality team Ensure the implementation of Sanofi GQDs through gap analysis and determination of resources needed for the implementation. Final disposition decision for batches with major deviations or OOS. Final approval of investigations affecting product quality (Failure investigations, out of specifications) ensuring the root cause identification, corrective actions and preventive measures needed to prevent re-occurrence. Ensure the final decision of product recall follow the Local recall committee decision. Ensure performing annual quality system review and communicate it with site management. Ensure the required training identified for all team member and completed in due time Ensure that GMP Training programs are in place and managed according to company directives and covers training needs. Managing / Monitor all Quality commitments including CAPA Closure on time Ensure the site validation Master plan and site internal audit plan is prepared and approved on annual basis. Establishment of appropriate Quality KPIs according to local system review and company strategies. Sustain the relevant HSE, QA, and SMS KPI metrics according to the appropriate SOPs, GMP and HSE guideline Leading *** and OPEX for the departments, ensuring the budget utilized efficiently according to agreed plan HSE, Environmental, Health and Safety Leadership Create a positive safety culture, safe and healthy working environment Develop and Comply with all safety rules issues by the Company, ensure all HSE policy is communicated to all employees with proper training and records Manage / Ensure Immediate reporting of any accident, incident or near miss, including and not limited to personal injury or property damage Ensure/ Develop all Safety standard, SOPs, assessments, reports are up to date, in place, in use and effective Providing all HES commitments on target date Commitment to the appropriate PPE use. People Leadership Role modelling the expected behaviors and standards for all staff in the area Supports the professional and career development, ensuring the development plans are in place and reviewed on a regular basis, ensuring that the training required is identified, recorded using the appropriate method, and provide opportunities to learn and practice new skills. Lead and build a motivated, inspired and engaged team through recognition, regular communications, and encouragement of cooperation between individuals and teams Engaging all staff in the future strategies by sharing the vision, area objectives and helping staff to understand the value adding of their work to the team and business Provides appropriate and timely feedback about performance and coaching the team members to help them achieve their goals Identifying key talent and capabilities and input to succession planning process Quality GMP Requirements Compliance to SFDA and Sanofi quality standard. Effective participation and enhancements of quality standard. Keep area ready for any quality Self Inspection Audits Maintain Compliance Respect of Company’s values, Code of Ethics Ensure implementation of all SFDA requirements (Including new ones). Develop /execute all corrective and preventive actions (CAPA) linked to production activities to assure timely compliance and continues improvement. Ensure the root causes of deviation or non-compliance are identified and put in place CAPA with regular follow up. KEY WORKING RELATIONSHIPS INTERNAL Cross Functional Collaboration with: Entire Site Team Other Sanofi stakeholders EXTERNAL Would be expected to be involved with: External suppliers Third Party (Service Provider) SKILLS, EXPERIENCE KNOWLEDGE REQUIREMENTS Education Level Bachelor’s degree in pharmacy, sciences, or any related field related to quality Msc Degree is a Plus. Experience Minimum of 05 years in Quality of pharmaceutical company Previous experience in Multinational Company is a Plus Skills Knowledge of GMP and SFDA regulations Leadership, Good communication skills Problem solving skills Statistical knowledge TQM tools Fluency in Arabic / English Ability to work under pressure. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.