Transversal Gxp Corporate Process Owner

Il y a 8 mois

Brainel'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, and Investigation Management comprising a scope of multiple GxP domains and/or departments. You’ll be accountable for the process across the entire organization and across the different regulatory domains. You’ll also ensure corporate process alignment amongst regulatory domains and departments, continuous improvement/efficiency of these processes, all while ensuring process(es) are compliant with the applicable regulations.
- A CPO Governance Lead role. You’ll build, maintain and give direction to a cross-functional network of Transversal CPOs, Domain CPOs and Entity Process Owners (EPOs) where applicable, leveraging the appropriate governance to ensure the appropriate level of engagement and cross-functional consistency. This will be achieved through close working and partnering with colleagues across domains and applicable departments.

Who you’ll work with:
Reporting directly to the Head of GxP Quality Management Systems and collaborating with a cross-functional network of stakeholders, the Transversal Corporate Process Owner provides leadership and strategy to ensure the definition, development, implementation, and lifecycle management of UCB’s transversal Deviation Management, CAPA Management and Investigation Process and System and has responsibility for UCB’s Governance for Corporate Process Ownership.

What you’ll do:
Transversal GxP CPO Deviation Management, CAPA Management and Investigation
- Take ownership as Transversal Corporate Process Owner of Deviation Management, CAPA Management, and Investigation under the GXP QMS and be accountable for designing an effective and efficient process, delivering quality outcomes as required within the organization.
- Ensure that the process is clearly defined, designed, and documented (Policies and Procedures) at corporate level and across the different domains. In this regard, you’ll work closely with but also be supported by CPOs of other processes using CAPA (complaints, audits, management review), investigations (deviations, complaints, out-of-specification) and Domain CPOs (e.g., Deviations).
- Own the transversal or global documentation (UCB policy, standard & procedures) and training (if relevant) linked to the assigned Quality System Processes. You have oversight for domain documentation and training strategy with an alignment of training needs analyses.
- Provide QA expertise in driving strategic and operational Quality Assurance alignment and decision making associated to any process adaptations and improvements linked to the change of the IT system which is used for the processes owned by the tCPO. You’ll also set strategy for system and its use with domain CPOs and PDO (Process Data Owner).
- Implement a Global approach to have Global Process(es) in promoting alignment with Domain CPOs.
- Establish and build a network with Domain CPO’s and EPO’s in relation with the identified process, where applicable, leveraging the appropriate governance to ensure the appropriate level of engagement.
- Ensure transversal alignment for assigned processes across GxP disciplines (strategy for process) and departments.
- Maintain a communication plan on changes, improvements, and Best Practices. You will be accountable and perform the Quality System Monitoring Report (QSMR) for transversal CAPA Management used in the Management Review Process. Contributes to QSMRs for Deviation and Investigation issued by Domain CPOs and monitors the process performance across GxP for the assigned processes including identification of risks and areas for improvement.
- Collaborate with Quality Compliance & Auditing, to align auditor expectations & potential preparation on process specific topics for internal/external audits and inspections.
- Ensure Change management across the organization, for any changes implemented on system or process, in relation with the identified process.
- Coach professionals by providing expert advice and support in relation with the identified process.
- Build, establish, and develop a governance model and process which fosters continuous process improvement.
- Ensure that the right Key Performance Indicators are developed and used to monitor the outcome of the process, promoting the cascade of these KPIs from the QALT across the organization and across domains.
- Single Point of contact for the PDO to support update to the IT systems used for the process
- Provide inspection support to health authority inspections at UCB sites and inspections of UCB Quality Management Systems as needed to maintain UCB’s Operations in accordance with Health Authorities issued regulations and

  • Transversal Gxp Corporate Process Owner

    Il y a 7 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,...

  • 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 & 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 Gxp Data Integrity

    Il y a 7 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...

  • Head Gxp Quality Systems

    il y a 1 semaine

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Make your mark for patients** We are looking for a high caliber, self-motivated**, **Head GXP Quality Management Systems** based in **Braine l’Alleud, Belgium** **About the role**: The GXP QMS scope includes UCB preclinical, clinical and CMC products development, manufacturing, analytical and distribution activities to ensure they are complying with...

  • Gmdp Corporate Process Owner

    Il y a 4 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...

  • Quality System Management Lead

    Il y a 7 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,...

  • Quality Process Data Owner

    Il y a 2 mois

    Braine-l'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...

  • Quality Process Data Owner

    Il y a 7 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...

  • Head of Quality Digital Industrialization

    Il y a 2 mois

    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...

  • Head of Global Quality Auditing Business Operations

    Il y a 4 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Global** **Quality Auditing **department, we are looking for a talented profile to fill the position of**:Head of Global Quality Auditing Business Operations - Braine l’Alleud, Belgium** **About the role** The main objective of this role is to lead the Business Operations unit within Global Quality...

  • Km Value Analyst

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** Knowledge Management aims at facilitating and accelerating the access to information and to identify new opportunities of growth as well as enabling our quality system (ICH Q10) Creating and implementing UCB’s Knowledge Management processes and solutions is key to help information and knowledge flow to the right people at...

  • Process Manager

    il y a 1 semaine

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Make your mark for patients** We are looking for a **QMS & Process Compliance Manager **to join us in our **CMC DEV Business Excellence, Sourcing & Operations** team, based in **Braine-l’Alleud**, **Belgium** **About this transversal role** You play a key role to ensure: - The implementation of Quality Management System (QMS) and of the related...

  • IT Manager Testing Coe

    Il y a 4 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **IT Tech Strategy & DBT Solutions **team, based in Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of**:IT Manager Testing CoE.** **About the role**: The testing manager will ensure the continuity of IT testing activities, further develop IT testing automation...

  • IT Manager Testing Coe

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **IT Tech Strategy & DBT Solutions **team, based in Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of**:IT Manager Testing CoE.** **About the role**: The testing manager will ensure the continuity of IT testing activities, further develop IT testing automation...

  • Site Process Validation Expert

    il y a 1 jour

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Make your mark for patients.** We’re here because we want to build the future and transform patients’ lives for the better. At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care...

  • Head of Global Quality Auditing Business Operations

    il y a 7 jours

    Braine-l'Alleud, Wallonia, Belgique UCB Temps plein

    Make your mark for patientsTo strengthen our Global Quality Auditing department, we are looking for a talented profile to fill the position of: Head of Global Quality Auditing Business Operations – Braine l’Alleud, BelgiumAbout the roleThe main objective of this role is to lead the Business Operations unit within Global Quality Auditing, serving as a...

  • Site Process Validation Expert

    il y a 3 jours

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Aidez-nous à transformer la vie des patients.** A UCB, nous mettons tout notre cœur, notre âme et nos compétences pour faire la différence pour les personnes vivant avec une maladie sévère. Travaillant ensemble pour repousser les limites, nous combinons le meilleur de nos talents pour libérer l’innovation. Voulez-vous nous rejoindre dans notre...

  • Biomanufacturing Process Lead

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** Nous recrutons un.e **Biomanufacturing Process Lead** ayant une habilité à transmettre ses connaissances tout en challengeant positivement et en argumentant, pour nous rejoindre au sein de notre nouvelle usine de production bio. **A propos du poste**: - Support opérationnel pour la réalisation des activités de...

  • Supply Chain Process Improvement

    il y a 1 semaine

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Make your mark for patients** We are looking for a **Supply Chain Process Improvement Coordinator **who is **structured, organized and able to drive Change Management,** to join us in our **Braine Supply Chain** team, based in our **Braine l’Alleud’s **office in **Belgium.** **About the role** Your objective is to support Braine Supply Chain by: -...

  • Head of Quality Digital Industrialization

    il y a 7 jours

    Braine-l'Alleud, Wallonia, Belgique UCB S.A. Temps plein

    Make your mark for patientsTo 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, BelgiumAbout the roleThe Head of Quality Digital Industrialization is a leadership role that drives the digital transformation of the Global Quality...