Job Overview
Sanofi is committed to building a healthier, more resilient world through innovative medicines and vaccines. The Global Quality System Process Manager will play a crucial role in ensuring a compliant and effective Quality Management System (QMS) that aligns with global regulatory and Good Pharmacovigilance Practices (GVP).
Key Responsibilities
- Sustainability of QMS: Ensure a sustainable and compliant QMS that adheres to GVP and legal standards from global to local levels.
- Monitoring and Tracking: Create and maintain systems for effective monitoring and tracking of pharmacovigilance activities.
- Risk Identification and Management: Identify potential compliance risks and oversee improvement programs to mitigate them.
- Inspection Readiness: Prepare the organization for audits and inspections, including follow-ups and documentation.
- Document Management: Oversee the preparation, lifecycle management, and timely availability of global Quality Documents (QDs) within the Electronic Document Management System.
- Quality Event Management: Manage quality events such as deviations, CAPAs, and change controls in a timely manner.
- Training and Monitoring: Ensure the PV QD Training Matrix and training curricula are current and maintained.
- Corrective and Preventive Actions: Oversee the investigation of quality gaps and risks, ensuring effective implementation of corrective actions.
- Risk Analysis and Reporting: Conduct quality risk assessments, document findings, and report escalations.
- Vendor Qualification: Coordinate vendor qualification processes, track assessments, and monitor deliverable quality.
Candidate Profile
- Experience: Relevant professional experience in data management and report issuance.
- Soft Skills: Strong problem-solving ability, attention to detail, good organizational skills, and collaborative mindset. Must be adaptable, analytical, and proactive.
- Technical Skills: Proficiency with quality systems (e.g., Veeva, Kneat, LIMS) and Microsoft Office Suite.
- Education: Bachelor’s degree in Pharmacy, Chemistry, Biology, or related fields is required. A master’s degree is preferred.
- Languages: Fluency in English is required. Proficiency in French or other languages is a plus.
Additional Information
- Location: Hyderabad, India
- Industry: Pharmaceutical/Healthcare/Clinical Research
- Application Deadline: 30th November 2024