Site Quality Head

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 CAPEX 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.