Expert, Quality Operations, External Manufacturing Management

Job title: Expert, Quality Operations, External Manufacturing Management

• Location: Hyderabad

About the job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. This position manages a portfolio of Contract Manufacturing Organizations and Suppliers ensuring comprehensive quality oversight, including management of Drug Products and Drug Substances (APIs). The Expert ensures compliance with GxP, approved product dossiers, local regulations, and Sanofi requirements, serving as a quality focal point for manufacturing, testing, and release activities.

Main responsibilities:

• Quality Focal Point & Oversight: Serve as quality contact for assigned CMO/Supplier portfolio, monitor and evaluate quality KPIs, lead annual quality evaluations, prepare quality presentations for Business Reviews and coordinate inspection support.
• Quality Event & Risk Management: Manage quality events from receipt to closure ensuring proper investigation and CAPA implementation, assess batch disposition decisions and escalate risks as needed, conduct quarterly risk reviews and analyze trends to identify systemic issues.
• Change Control & Technical Assessment: Evaluate change requests for quality impact, regulatory compliance, and supply continuity, participate in Change Control committees as quality expert.
• Audit & Compliance Management: Oversee audit follow-up, CAPA completion, organize sterility assurance reviews and approve serialization go-live agreements, review and approve Product Quality Reviews (PQR).
• Documentation & Systems Management: Approve SAP Quality Information Records (QIR) and Bill of Materials (BOM), review operational documentation, certificates of analysis, and manage stability programs.
• Continuous Improvement & projects: Drive quality improvements, support divestment processes.

About you:

• Experience: 5-8 years professional experience in pharmaceutical quality assurance, including experience in manufacturing or distribution sites. Strong knowledge of CMO/supplier management.
• Soft skills: Excellent communication. Proven ability to work with multifunctional and multicultural teams. Strong decision-making capabilities with rigor and autonomy. Ability to identify situations requiring escalation. Flexible and adaptable to complex environments.
• Technical skills: In-depth cGMP knowledge and pharmaceutical operations expertise. Proficient in quality systems (Veeva or similar platforms), SAP, data analysis tools. Strong analytical and problem-solving skills. Good knowledge in lean manufacturing is a plus.
• Education: Pharmacist or advanced degree (e.g., Master's, PhD or equivalent) in Engineering, Pharmacy, Chemistry, or related field
• Languages: Fluent professional English (written and spoken)

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.

null