Cmc Development Quality Lead

il y a 1 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Global Quality Assurance **department, we are looking for a talented profile to fill the position of**:CMC** **Development Quality Lead **- Braine l’Alleud, Belgium**

**About the role**

As part of the CMC Quality Management organization, specifically within the CMC Development Quality group, you will lead strategic quality management across CMC Development Sciences groups in their product and process development activities, adhering to ICH guidelines.

This profile will ensure that quality and compliance issues are managed with diligence, rigor, and transparency in all CMC activities. This includes supporting product and process development, clinical supply manufacturing, analytical work, technology transfer, CMC filing, and more, from early phases to the commercial launch of the product. The goal is to ensure product quality and compliance with regulatory requirements, while meeting business performance expectations.

**You will work with**

To ensure effective QA leadership for their product development projects, the CMC Development Quality Lead will closely collaborate in a lean, efficient, and trustworthy manner with all functions involved in CMC and GMP strategic activities throughout the lifecycle management of global pharmaceutical and biological products. This collaboration aims to ensure the development of high-quality, safe, and efficacious products. Additionally, there will be a collaboration with other global QA functions, including GMP/GSP Quality Operations, to manage the operational aspects of clinical and development batch manufacturing.

**What you will do**
- From early development stages up to Proof of Concept (PoC) included:

- Proactively provide guidance and advice to CMC Development Sciences Project Technical Solution Team (Project TST) representative members, particularly with regard to the appropriate use of UCB Quality by Design (QbD) guidelines, and interpretation of national and international cGMP regulations and ICH guidelines
- Ensure that CMC project related Quality Assurance activities are consistent across the range of different environments and teams supported (Vendors & Strategic Suppliers / UCB in house manufacturing / UCB Partners)
- Review and approve adequate documentation made available and followed for CMC development projects (Process & manufacturing descriptions / Specifications / Justification of specifications / Analytical methods / Change controls / Validation protocols, Deviation impacting product & process control strategy, including Out of specification and Out of trends) for all CMC and clinical supply related activities
- Responsible for leading participation in partnerships with other departments to identify, mitigate and subsequently resolve compliance and quality issues that may affect UCB development activities and products. These lessons learned once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities
- Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions
- Partner with project teams to address operational deficiencies identified by regulatory Agencies.
- Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems, developing solutions, guidance and procedure.
- For product late-stage development up to commercial launch:

- Ensure quality oversight on TST decisions that frame-up CMC strategy and documentation package for late-stage development: Technology transfer, product and process control strategy, process comparability between small and large scale manufacturing, process characterization, process validation, validation of analytical methods, product characterization, product stability, and pre-approval inspection readiness
- Coordination of and oversight on the Quality Assurance group members responsible for QA review and approval of late-stage development documents
- Ensure progressive transfer of product and process control strategy documents to CMC Quality Lead who will ensure accountability of product quality oversight in the commercial phase
- Organize and directly contribute to Quality Assurance review of CMC file (development sections) prior to submission to health authorities
- Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions
- Partner with project teams to address operational deficiencies identified by regulatory Agencies
- Ensure that all operations are appropriately compliant with applicable regulations (EMA, FDA, DEA, MHRA, OSHA, DEC, etc. where relevant). As

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