Work as Quality Management Systems Head at Sanofi

 

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.

Post : Quality Management Systems Head

Job Description
Mission statements

• Coordinate the implementation of quality systems in accordance with GxP and the Group guidelines and ensure their application on site through :
• Management tools (ITS systems and SOPs)
• Self-inspections
• GMP training program
• Vendor/Supplier qualification
• Ensure continuous improvement of the Quality Systems.
• Drives the performance of quality systems with quality KPI and quality committee.
• Ensure compliance through APR and group policy evaluation.
• Ensure control of changes.
• Coordinate inspection preparation program
• Is responsible for the following processes : Deviation & CAPA, change control, GMP training, Quality risk management

Management :
• Manage human resources and ensure people development of his/her team members
• Evaluate and manage resources (QA and other services) to ensure project success (inspections, audits, action plan follow up)

Quality systems and documentation:
• Is the SME for GMP Directives and guidance
• Translate quality policy into operational actions
• Ensure systems compliance through in place-in use evaluation program
• Ensure Training Management System in compliance with GxP and Sanofi requirements
• Ensure training plan roll out
• Approve master documents related to GMP
• Propose continuous CAPA plan link to trend analysis (APR, Site quality review KPI, audits reports, training reports, Deviation trending, etc.)
• Establish good documentation control
• Integrate risk management principles into Quality Systems and inform management on quality risks
• Ensure compliant Deviation, CAPA and Change Control handling at site
• Organise change contol comitee and change evaluation
• Design and monitor Quality KPIs

Audit and compliance:
• Establish self-inspection plan and ensure feasibility of self-inspection program and its roll out
• Organise and prepare inspection and ensure training of involved persons (SMEs, leaders, backroom, etc)
• Ensure Vendor / Supplier qualification
• Ensure Inspection readiness at all times
• Implement Inspection readiness tool on site
• Demonstrate visible commitment to HSE and show special responsility to lead by example

Candidate Profile
• Minimum of Bachelor Degree or Masters in Science or Pharmacy is required.
• Minimum of 12 years of relevant experience in similar position
• Demonstrated ability to think / work in a well-structured way
• Pharmaceutical industry experience is a plus
• Proven ability to cooperate transversally
• Proven ability to Act for Change
• Ability to lead Teams with good interpersonal skills
• Excellent communication skills
• Well-structured way of working / thinking
• Language requirements: advanced English skills

Additional Information
Experience : 5+ years
Qualification : B.Sc, M.Sc, B.Pharm, M.Pharm

Location : Toopran Mandal, Telangana
Industry Type : Quality Management
End Date : 20th July, 2019

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