Job title: Regional Quality Documentation Sr 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:

• Execute administration and governance related tasks:
• Identify opportunities for format improvement: Format monitoring for alignment with local strategy
• Identify opportunities for process improvement: interaction with local Doc Governance team, and support to doc strategies
• Understand the applicability of the documents and stakeholders, challenge the stakeholders, review stakeholder list & manage list for review and distribution
• With a focus on initiation of quality documents (QD) workflow management: share all information needed: Identify authors, applicable templates sharing, document change request (DCR) communication if applicable, draft generation in QualiPSO (ID, metadata creation), final draft cleanup before approval
• Manage and monitor the documentation update process, with periodic review process, in support to local document governance
• Participate to local document governance meetings
• Coordinate gap assessment process: Monitoring of STD assessment and GOP Direct use decision: ensure progress of the process done by local SMEs with local doc Governance, report and KPI
• Prevent gap assessment process from other non-standardized approach
• For local document initiation: Creation of the Doc ID in QualiPSO and metadata - manage the creation and update of metadata, understand the applicability of the documents/stakeholders, challenge the stakeholders, & implement communication strategy based local doc governance
• Support sites/entities and internal client: Q&A redirection on doc content to experts : Direct questions to the appropriate authors and subject matter experts (SMEs) and providing expert responses, first level answer for simple questions (on doc processes), data extractions, report generation, questions about QualiPSO metadata
• Support DCR process – Monitor DCR process including pre-assessment & support doc update according to CR process.
• Prevent Change Request process from other non-standardized approach
• Support communication on Global Quality Document approval, and generate QualiPSO extraction on demand

About you

Experience: >3 year professional experience in documentation, (optional: 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, Leadership of multinational teams

· Education: Bachelor or Master Degree

· Languages: Excellent English communication and writing skills; Portuguese proficiency is a plus.

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.

Pursue Progress. 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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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, ability or gender identity.

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