Regional Quality Documentation Specialist

Job title: Regional Quality Documentation Specialist

• 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 Regional Quality Documentation Manager within our team will be 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.

Main responsibilities:

• With a focus on initiation of quality documents (QD) deliverables
• Create DocID in QualiPSO and metadata: manage the creation & update of metadata
• Implement updates of applicability of the documents and stakeholders, update picklist (e.g. material, buildings, etc…)
• Implement communication strategy based on local document governance
• Coordinate transversal Content Management System (CMS) QualiPSO administration – check user access and privilege (care request management), training assignment and annual review access
• Support good documentation practices training and communication
• Support document change request (DCR) process – Support monitoring of DCR process including KPI, DCR sharing for decision (to author and local Doc Controllers)
• Support periodic review by monitoring periodic revision process with KPI, interaction with Author/local Doc Controllers, launch of periodic revision process in the tool

About you

· Experience: >1 yrs professional experience in documentation, in GxP environment ´

· Soft 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

· Technical skills: Strong skills in Quality DMS, Word, Excel, Powerpoint

· Education: Good administrative experience, Bachelor Degree preferrable

· Languages: Excellent English communication and writing; additionally, at least one of the following: 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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