Evf Quality Computerized System Owner

**Location**

Singapore, Central Singapore

**Job Type**

Permanent

**Salary**

$6,000 - $11,500 Per Month

**Date Posted**

4 hours ago

Additional Details

**Job ID**

94537

**Job Views**

1

**Job Description**:
Roles & Responsibilities
**Context**

Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Vaccine Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine public health’s necessity and ensure tomorrow’s vaccine production and fostering alternative compatible biotechnical process (i.e. mRNA, enzymes ).

This ambitious project pursues 4 main characteristics:

- Multiproduct manufacturing modules, flexible areas or “ballrooms” switching from one process/product to another, while guaranteeing regulatory requirements compliance
- An evolutive building able to reach 3 times its initial capacity if needed
- Advanced technologies adapted to various manufacturing standardized platforms
- High digital ambition (cobots, digital twins, artificial intelligence, increased workforce, cloud-based architecture)

In this context, we are looking for an EVF Quality System Owner.
**Mission**

In compliance with Quality & Health Safety Environmental site rules, the EVF Quality System Owner is responsible to assess, design, roll-out and maitain compliant, robust and optimized Quality Digital Solutions across EVF sites, in alignement of regulatory requirements, EVF ambition and sanofi standard.

The EVF Quality System Owner represents the systems area.
- **
Act as Business System Owner (BSO**) and ensure Computerized Systems Governance and Compliance through roll-out projects & maintenance activities
- Ensure Computerized System (CS) and Data Integrity (DI) requirements are adressed into the design of Digital Solutions, in alignment with Sanofi Standards
- Ensure alignement of EVF digital quality ambiton and sanofi global quality strategy regarding digital transformation
- Define and implement the quality management of digital solutions (governance and processes) for operations & maintenance at EVF scope (management of users training, access, users support, change control, data integrity, Business continuity, Quality events, periodic review, Audit trail)
- Is the EVF Data integrity referent for digital solutions and the Point of contact for Digital solutions during Health Authorities communication/Inspections.
- **
Interfaces Mangement**:

- Interacts constanly with the EVF Quality Team, Quality Key user, and Digital Team
- Builds & cultivates constructive interfaces with Global Quality and Pasteur Centers of Excellence related to Technologies & data
- **
Human factor / Change management**: “Demistify” Digital to EVF Quality Team and promote how digital solutions can support the future in terms of quality processes (Quality System, QC, QA operations) and ways of working
- **
Budget, Resources, priorities & timelines**
- Is responsible for appropriate prioritization, supporting resources needs definition and allocation for CS User related activities, regarding Solutions (project & maintenance) activities
- **
Decision framework**:

- Assess and take appropriate decisions on Quality Solutions strategies and Priorities for both EVF sites (Brownfield and Greenfield)
- Can handle or support EVF Business Process Owner activities (BPO) or other Quality Manufacturing 4.0 activities, as applicable.
**Scope and dimensions**

Breadth of responsibility (global/regional/country/site):

- Position based in Sinagapore site (Tuas)
- 2 EVF sites in scope, whatever the job location
- Potential trips abroad (maximum 10% of work time)

Key dimensions: headcount (direct and indirect), budget, doses, Capex
- Largest Program. Large impact on innovation SP ambition. Extensive scope and complexity; effective cross-functional interaction, global networking, communication & change management
**Education and experience**

Specific degree, duration of experience (Required to hold the job):
Pharmacist, Scientist or Engineer with about 5 years of experience in Computerized system within within regulated environments (Quality, Manufacturing, R&D, )in the pharmaceutical or biotechnology industry.

Key technical competencies and soft skills:

- Project Management & Manufacturing 4.0 mindset (Agile methodology)
- Knowledge and experience of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
- Knowledge and experience of the systems and technologies of the covered sector.
- Problems management: adaptation to variable situations requiring analysis and constructive & collaborative thinking. Capacity in analysis and sorting out problems
- Fluent in English (B2 level)
- Take action / Stretch be