Quality Alert Manager

About Sanofi’s Consumer Healthcare (CHC) Vision:

Sanofi’s Consumer Healthcare division aims to lead the next health revolution by empowering consumers to take charge of their own health, fostering self-care and wellness across categories like Allergy, Digestive Wellness, Pain, Mental Wellness, Cough, Cold & Flu. The company is committed to creating a trusted, innovative brand portfolio that enhances well-being while also contributing to a healthier planet

ABOUT THE JOB

Our Team

The Quality Alert manager is a member of the CHC Quality Risk Management team. This team is part of the Risk management and Compliance department CHC within CHC Global Quality.

Our Risk management & Compliance team serves as the guardian of patient safety, customer satisfaction, and service quality, as well as ensuring a robust product life cycle management.

• By formulating and implementing the CHC Quality Strategy for proactive and reactive quality risk management, and fostering a quality risk culture throughout CHC entities/sites and affiliates.
• By ensuring that products adhere to regulatory compliance aligned with the strategic directions of Sanofi and CHC entities, in accordance with global health regulations.
• By consistently enhancing and refining our processes, plants, and affiliates' compliance with Health Authorities' requirements.
• By proactively anticipating regulatory developments and changes.

Main Responsibilities

Under the supervision of the Quality Risk Management Head, the incumbent will

• Deploy and maintain Quality Alert Management processes (Quality alert, Product alert and recall management), and provide support, expertise, guidance for operational management as needed
• Lead the end-to-end management of quality alerts raised for GXP quality events, warranting communication and coordination of mitigation plans between several responsible entities (e.g., batch recall, product shortage, product defect notification to Health Authorities, batch blockage). Define strategy for timely notification to Health Authorities in compliance with local regulations and Sanofi policy
• Assess the Quality Critical risks portfolio and identify needs of transversal action plan with Quality Operations (Risk Review, Risk Management Report)
• Coordinate the management of product recall :
• Ensure compliance of documentation needed to support the decision making and recall implementation
• Convene the Global recall decision committee
• Coordinate recall implementation up to markets, ensure follow up of returned units until closure
• Contribute to sharing the Critical events leading to Quality Alerts and related mitigation plans with the Quality Operations in order to prevent the reoccurrence of similar events
• Ensure sharing of experiences through identification and communication of best practices, key learnings and actions on continuous improvement
• Contribute to the implementation of consistent Quality Alert management, product recall management and product alert processes, define training strategy to the process and tools, and identify process improvement opportunities
• Identify training needs within the defined perimeter and provide appropriate training
• Operate as a vertical organization empowered to make decisions to simplify, harmonize and optimize the processes with the right expertise.
• Scope: Worldwide countries and CHC manufacturing and distribution sites

ABOUT YOU

• Experience: Minimum 10 years’ experience in Quality functions with GMP/GDP/GxP activities with broad scope (drug products, medical devices, nutraceuticals, cosmetics)
• Soft skills: Problem solving, Communication skills, Internal and external networking capability, Leadership and assertiveness skills, Decision making
• Technical skills: Advanced knowledge of regulations applicable to Medicinal products for Human Use (US FDA, EMEA requirements/international guidelines, ICH); Practical knowledge of Pharmaceutical Operations
• Education: Holds a degree as a Pharmacist or an advanced degree (such as a Master's, PhD, or equivalent) in life sciences or related fields.
• Languages: Proficient in French AND English, both spoken and written

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com.