Quality Process Data Owner

Il y a 5 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

We are looking for a **Process Data Owner** (PDO) for our **Veeva Vault QMS** (Quality Management System) to join our Quality Data and Digital Solutions team, in Braine l’Alleud.

**About the role**

In this role, you will act as the Single Point of Contact between the Quality and IT organizations, consolidating and aligning various quality requirements and translating them into technology requirements for successful implementation.

In this role, acting as **Veeva Vault QMS Business Administrator**, you will be responsible for ensuring:

- The complete and compliant rollout and utilization of the Veeva Vault QMS on a global basis in collaboration with other Quality groups, IT, and other applicable business areas.
- The continuous maintenance of the solution in a compliant state (validation, current procedures, etc.).
- The maintenance and enhancement of cross-functional cooperation between Business functions, Quality, IT, and/or Vendor organizations as it relates to the system in scope.

**Who you'll work with**

This role is positioned within the Quality Data and Digital Solutions team, a team composed of several business solution experts for both Quality processes and Documentation Management, responsible for the business implementation and continuous improvement of the Veeva Quality Suite, working with cross-functional teams to ensure compliance with industry regulations and streamline quality processes.

**What you'll do**
- Providing input to and implement a strategy for defining, developing, configuring, implementing, rolling out, and continually maintaining and improving the systems in scope for sustained compliance with pharmaceutical regulations.
- Ensuring that systems in scope are configured in line with common platform (software) requirements, including the Data Model, to facilitate current and future automated connectors.
- Maintaining systems in scope in a constantly validated state of control and author, review, and/or approve validation deliverables.
- Developing and implementing governance to ensure compliant and efficient lifecycle management of systems in scope.
- Collaborating with other functional teams responsible for different systems to facilitate integrations.
- Ensuring new guidelines and regulations pertaining to systems in scope are reviewed, monitored, and implemented.
- Monitoring industry trends and discuss their potential impact on internal strategies.
- Ensuring inspection and audit readiness of the solutions under the scope of the Quality Innovation & Strategic Planning team.
- Establishing and developing KPIs and metrics in collaboration with the Quality Dashboarding responsible.
- Proactively seeking continuous improvement and sharing best practices solutions and processes in terms of organization, positive attitude, harmonized work style, and customer focus.
- Writing, reviewing, and/or approving SOPs, Change Control, Complaints, Deviations, Investigations, and/or CAPA related to the computerized system in charge.
- Acting as a facilitator and contributor in defining global communication needs for the different owned systems.
- Acting as an influencer, coach, and facilitator within different internal and external communities related to the managed systems in scope.

**Interested? For this role we’re looking for the following education, experience and skills**
- Minimum Level of Education Required - Bachelor’s Degree
- Preferred Level of Education - Veeva Certification
- Area of Specialization - Veeva Vault/Vault Quality Suite/ QMS
- 5 or more years of experience in administration or maintenance of Quality Management System (preferably in the biosciences or pharmaceutical industry).
- Proficiency in GxP Pharmaceutical Regulations (EMA, FDA, ICH), including those specific to computerized systems.
- Good knowledge of validation requirements for computerized systems in the pharmaceutical environment.
- Proven multi-project management skills and competence in driving cross-functional projects.
- Excellent influencing, collaboration, and leadership skills, particularly within multi-cultural and virtual environments.
- Strong process improvement skills and orientation.
- Must have proven business and technology skills with success providing customer-oriented technology solutions environment.
- Proven strong communication skills interacting with user and technical communities.
- Ability to communicate ideas in both technical and user-friendly language.
- Collaborative working approach.
- Excellent communication skills in English.
- Implementing a risk-based approach.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 peo

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