Team Lead, Quality for External Manufacturing Management

Job title: Team Lead, Quality for 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 leadership position manages a portfolio of Contract Manufacturing Organizations and Suppliers, providing quality oversight for Drug Products and Drug Substances (APIs). The Lead ensures compliance with GxP, regulatory requirements, and Sanofi standards while driving quality excellence, team development, and continuous improvement across the CMO/Supplier network.

Main responsibilities:

• Strategic Leadership & Quality Governance: Lead quality oversight strategy for assigned CMO and Supplier portfolio serving as senior quality focal point for Sanofi departments and external partners, drive strategic quality initiatives at hub level and quality excellence programs across CMO/Supplier network, establish and monitor quality KPIs leading annual quality evaluations and risk ranking processes, present quality strategy and performance at CMO Business Reviews and senior leadership forums, mentor and develop team members providing technical guidance and quality expertise.

• Advanced Risk & Quality Event Management: Oversee complex quality event investigations ensuring robust root cause analysis and effective CAPA implementation, lead escalation and crisis management for critical quality events, conduct quarterly risk reviews and implement proactive risk mitigation strategies, analyse quality trends across portfolio to identify systemic issues and drive preventive actions, make critical decisions on batch dispositions with significant business or patient impact.

• Audit, Inspection & Compliance Leadership: Support CMO and Supplier audit programs including execution oversight, and CAPA effectiveness verification, coordinate regulatory inspection support.

• Change Control & Technical Excellence: Oversee change control evaluations with significant regulatory or business impact, participate in Change Control committees as senior quality expert, provide technical expertise on manufacturing processes, analytical methods, and quality systems, approve critical quality documentation including PQRs (Product Quality Review), stability programs, and serialization implementations.

• Cross-Functional Collaboration & Influence: Partner with Supply Chain, Regulatory, Global Quality, and Commercial teams to align quality strategies, influence CMO and Supplier quality culture and performance improvement, build and maintain strong relationships with CMO and Supplier senior management.

• Continuous Improvement & Projects: Identify and implement quality improvements, drive lean manufacturing and quality excellence methodologies within the team (e.g., Boom), contribute to quality standards development and harmonization, lead special projects as API sourcing / divestments / pruning.

• Budget & Resource Management: Provide strategic input into department budget planning, manage quality activity budgets and resource allocation, optimize quality oversight processes for efficiency and effectiveness.

About you:

• Experience: 8-10 years’ professional experience in pharmaceutical quality assurance with proven leadership track record. Extensive CMO/supplier management experience. Previous experience in manufacturing or distribution site leadership preferred. 

• Soft skills: Strong communication and influencing skills. Proven ability to lead and develop teams (direct management). Strategic thinker with strong business acumen. Excellent decision-making under pressure. Adaptable, resilient, resourceful profile that is adaptable, thrives in fast-changing environments, and can manage ambiguity effectively. Cultural intelligence and ability to work effectively across global, multicultural environments. Strong stakeholder management capabilities. 

• Technical skills: Expert-level cGMP knowledge and pharmaceutical operations expertise. Deep understanding of regulatory requirements across multiple markets. Proficient in quality systems (Veeva or similar platforms), SAP, and data analytics tools. Lean manufacturing expertise. Project management capabilities. 

• Education: Pharmacist or advanced degree (e.g., Master's, PhD or equivalent) in Engineering, Pharmacy, Chemistry, or related field. Additional business or leadership qualifications a plus. 

• Languages: Fluent professional English (written and spoken) required.

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.