Quality Process Data Owner

il y a 1 semaine

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Quality System & Strategy** department we are looking for a talented **Process Data Owner** (PDO) - **Belgium - 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. Moreover you will be developing and implementing strategies for the Quality Innovation & Strategic Planning team to maintain systems that ensure compliance with pharmaceutical regulations. It includes adopting global standards for document and quality management, providing central support for a unified platform, and leading and mentoring team members. The role also involves acting as an influencer within internal and external communities, strategically partnering with QMS, driving continuous process improvements, and collaborating with development teams to facilitate seamless system integrations.

**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
- Area of Specialization - Veeva Vault/Vault Quality Suite/ QMS
- At least 3 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.

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 people in all four corners of the globe, inspired by patients and driven by science.

**Why work with us?**
At UCB, we don’t just complete tasks, we create val

  • Quality Process Data Owner

    Il y a 5 mois

    Braine-l'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...

  • Gmdp Corporate Process Owner

    Il y a 2 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **External and Clinical Supply Quality** we are looking for a talented profile to fill the position of**:GMDP Corporate Process Owner** **- Braine l’Alleud, Belgium** **About the role** This position will serve as the Corporate Process Owner (CPO) for several Quality Systems, including but not limited to...

  • Transversal Gxp Corporate Process Owner

    Il y a 6 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a Transversal GxP Process Owner able to work in highly dynamic environment to join us in our Quality Systems & Intelligence team. About the role Your job comprises the following main responsibilities: - A transversal GxP Corporate Process Owner Lead role (tCPO) for Deviation Management, CAPA Management,...

  • Corporate Process Owner

    Il y a 2 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Quality Systems & Governance **department we are looking for a talented profile to fill the position of**: Corporate Process Owner** **- Braine l’Alleud, Belgium** **About the role** The **Corporate Process Owner (CPO)** provides leadership and strategy to ensure the definition, development,...

  • Head of Quality Digital Industrialization

    il y a 1 jour

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Global Quality **department we are looking for a talented individual to fill the position of**:Head of Quality Digital Industrialization** - Braine l’Alleud, Belgium** **About the role** The Head of Quality Digital Industrialization is a leadership role that drives the digital transformation of the...

  • Quality Kpi Specialist

    Il y a 5 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** **We are looking for a** Quality KPI Specialist **who is agile and conscientious to join our team, based in **Braine, Belgium**.****: **About the role**: **The Quality KPI specialist is responsible for the design and management of Quality Metrics that give an overview of the collective quality performance at the company...

  • Transversal Gxp Corporate Process Owner

    Il y a 4 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Quality Systems & Strategy Department** we are looking for a talented person to fill the position of: Transversal GXP Corporate Process Owner - Braine l’Alleud, Belgium **About the role** The **Transversal GXP Corporate Process Owner (CPO)** provides management and strategy to ensure the definition,...

  • Head Gxp Data Integrity

    Il y a 5 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** **About the Role**: Join our dynamic team as the Head GXP Data Integrity, reporting directly to the Head of Quality Systems & Strategy. This pivotal role entails providing leadership and strategy to ensure the integrity of UCB's GXP Data and Computer Systems Quality programs. Your mission will be to drive quality in our...

  • QA Equipment and Data Integrity Partner

    Il y a 5 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **QA Systems & Continuous Improvement Team**, based** **in **Braine, Belgium** we are looking for a talented individual to fill the position of**:QA Equipment and Data Integrity Partner.** According to QA S&CI team organization and in cooperation with Braine Technical Operations (BTO) and related supporting...

  • Data Governance Lead

    Il y a 2 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Data Governance Lead** who is **strategic, detail-oriented, and a proactive problem-solver** to join our **Data Strategy and Program** team, based in **Braine l’Alleud, Belgium.** **About the Role** As a Data Governance Lead, you will play a crucial role in developing and implementing data...

  • Data Analyst

    Il y a 4 mois

    Braine-l'Alleud, Belgique Enterpryze Consulting Ltd. Temps plein

    **Data Analyst - **Working Location**:Braine - l'Alleud, Belgium** - **Security Clearance**: NATO Secret** - **Language**:High proficiency level in English language **EXPERIENCE AND EDUCATION: **Essential Qualifications/Experience: - Minimum 3 years of experience with Microsoft SQL Server, SSRS (SQL Server Reporting Services), SSIS (SQL Server Integration...

  • Data Analyst

    Il y a 2 mois

    Braine-l'Alleud, Belgique Enterpryze Consulting Ltd. Temps plein

    **Data Analyst - **Working Location**:Braine-l'Alleud, Belgium** - **Language**:High proficiency level in English language **EXPERIENCE AND EDUCATION: **Essential Qualifications/Experience: - 3+ years of experience with Microsoft SQL Server, SSRS (SQL Server Reporting Services), SSIS (SQL Server Integration Services), SSAS (SQL Server Analysis Services) -...

  • Data Analyst

    Il y a 5 mois

    Braine-l'Alleud, Belgique Enterpryze Consulting Ltd. Temps plein

    **Data Analyst - **Working Location**:Braine - l'Alleud, Belgium** - **Security Clearance**: NATO Secret** - **Language**:High proficiency level in English language **EXPERIENCE AND EDUCATION: **Essential Qualifications/Experience: - 3+ years of experience with Microsoft SQL Server, SSRS (SQL Server Reporting Services), SSIS (SQL Server Integration...

  • Data Analyst

    Il y a 4 mois

    Braine-l'Alleud, Belgique Vector Synergy Temps plein

    **Location**: Braine L'Alleud, Belgium **Security Clearance**: NATO Secret **Reference No**: C002926 / Braine L'Alleud **Skills, knowledge, experience required**: - 3 years of experience with Microsoft SQL Server, SSRS (SQL Server Reporting Services), SSIS (SQL Server Integration Services), SSAS (SQL Server Analysis Services); - Experience with: - Data...

  • Data Analyst

    Il y a 2 mois

    Braine-l'Alleud, Belgique Uni Systems Temps plein

    At Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a Data Analyst to join our UniQue team in Braine-l'Alleud, Belgium! **What will you be bringing to the team?** - Takes responsibility for the accessibility, retrievability and securityof specific subsets of data. - Assesses the...

  • Quality Ops Partner

    Il y a 5 mois

    Braine-l'Alleud, Belgique Jefferson Wells Temps plein

    Location: **Braine-l'Alleud** **#23611** **Quality Ops Partner** Contracting - Brabant Wallon Our partner is currently looking for a **Quality Ops Partner **to join its team. This international company is well-known for its pharmaceuticals. **What are your responsibilities?** You will be part of the Development Quality Pharma Operational team and will...

  • Head of Bto Planning

    Il y a 2 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** **We are looking for a Head of Planning and Master Data** who is **visionary, focused on continuous improvement, and excellent at team management** to join our **Braine Supply Chain** team, based at our UCB campus in **Braine-l'Alleud, Walloon Region, Belgium**. **About the Role** As the Head of Planning and Master Data,...

  • Quality System Management Lead

    Il y a 5 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **GxP and GMP/GDP** **Quality Management System Lead **who is passionate, knowledgeable, and proactive to join us in our **GxP Quality Management Systems and Learning** team, based in our office in **Braine l’Alleud**, Belgium. **About the Role** As the GxP and GMP/GDP Quality Management System Lead,...

  • Compliance & Quality Systems Manager

    Il y a 5 mois

    Braine-l'Alleud, Belgique Jefferson Wells Temps plein

    Location: **Braine l'Alleud** **#23695** **Compliance & Quality Systems Manager**: Braine-l'Alleud - Contracting **What do we expect from you?**: Accountable/ responsible for ensuring the facilities is compliant with regulations and the standard quality systems in place, in collaboration with the owners of each individual area, which includes: - Access,...

  • Global Products Quality Solutions Head

    Il y a 5 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Global Products Quality Management **department, we are looking for a talented professional to fill the position of**:Global Products Quality Solutions Lead** **- Braine l’Alleud, Belgium** **About the role** Reporting to the Head of Global Quality Leads, this role in Global Quality Organization...