Stability Reporting Manager / Gerente de reportes de estabilidades

Job title: Stability Reporting Manager / Gerente de reportes de estabilidades

• Location: Bogotá, Colombia

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Stability Reporting Manager within our team will be to lead and oversee the regional stability monitoring team, focusing on effective management and strategic direction

Main responsibilities:

• Lead and oversee the regional stability monitoring team, focusing on effective management and strategic direction
• Analyze stability testing data using statistical software, ensuring accuracy, reliability, and adherence to regulatory requirements
• Review the stability reports to ensure strict compliance with established internal and external regulations and guidelines related to stability management for ongoing activities, including protocol development and report generation
• Develop team skills and foster continuous improvement initiatives to enhance operational efficiency and quality in Stability management
• Interface with regional hub leadership to ensure alignment and effective communication on Stability program.
• Coordinate with site-specific subject matter experts (SMEs) to gather insights and ensure comprehensive understanding of stability testing results
• Collaborate with cross-functional teams to implement process improvements and address any deviations or issues for stability management
• Implement and oversee training programs to ensure team members are proficient in stability management procedures and regulatory requirements
• Evaluate and optimize resource allocation to effectively manage the stability program.
• Serve as a key point of contact for sites during inspections and audits, ensuring compliance and facilitating smooth interactions

About you

• Experience: >8 years professional experience in pharmaceutical industry, quality control laboratories, stability management and managerial experience
• Soft and technical skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments.
• Thorough understanding and practical experience in applying ICH guidelines to ensure compliance in stability studies & quality risk management.
• LIMS, Word, Excel, statistical tools, GxP experience, stability regulation
• Education: BSc in Pharmacy, Chemistry, Engineering, or scientist professions (advanced degree preferred)
• Languages: Excellent English communication and writing skills; proficiency in one of the following languages is preferred: Spanish, Portuguese, or French.

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• You’ll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
• You’ll be part of a truly diverse cross-cultural team and can have real business impact.
• Flexible working policies, including up to 50% remote work.
• Private medical care, life and health insurance, and gender-neutral paid parental leave
• Colombia is one of Sanofi’s key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
• Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

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