Bio Manufacturing Science and Technology

Il y a 3 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **External and Clinical Supply Quality **department we are looking for a talented individual to fill the position of: Bio Manufacturing Science and Technology (MSAT) Quality Lead** - Braine l’Alleud, Belgium.**

**About the role**

The Bio Manufacturing Science and Technology (MSAT) Quality Lead ensures global quality oversight for MSAT activities in both internal and external manufacturing of bio drug substances, products, and packaging. This role involves leading and providing QA expertise for strategic and operational quality assurance, overseeing processes and investigations, troubleshooting, facilitating technical transfers, process validation, and continuous improvement. Additionally, the position ensures compliance with regulatory requirements and diligent management of quality issues.

**You will work with**

This will be achieved through close partnering in an efficient and collaborative way with Internal and External Bio MSAT, Bio MSAT Quality, Supply Chain, IT, Regulatory, Internal and External manufacturing operations and other team leaders in External & Clinical Supply Quality and within the Quality organization.

**What you will do**
- Establish and build a network with UCB key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products.
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Bio MSAT, with the following focus:

- Troubleshooting and ensure issues are resolved in accordance with policies and procedures
- Process improvement and life cycle management strategy
- Process industrialization and Technical transfers within commercial manufacturing facilities
- Complex investigations and associated CAPA plan implementation
- Oversight of process validation and continued process verification (CPV)
- Provide expert QA advice as required for the analytical activities associated with process transfers, process validation and investigations, including for example:

- analytical validation and transfer
- comparability (release, stability and characterisation)
- specification reassessment
- Support assignments associated with the products, or transversal projects across multiple products
- Build, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator-based performance monitoring
- Work closely with Global QA teams (CMC Quality, External & Clinical Supply Quality, etc), Patient Supply Teams and Business stakeholders in an effective and efficient way
- Promote quality best practices throughout the Internal Manufacturing Quality Team and the wider Global Quality Organisation and where possible business stakeholders. Create as needed simplified, efficient processes and procedures to support the team’s activities.
- Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development

**Interested? For this position you’ll need the following education, experience and skills**
- A master’s degree is required, ideally in a relevant field such as pharmaceutical sciences, biotechnology, chemistry, or a related discipline
- Excellent command of English, both written and spoken, with strong communication across all levels
- Excellent knowledge of the Biopharmaceutical industry from a business and technical perspective
- Able to work independently without direct supervision, handling complex situations that impact multiple departments
- Skilled in influencing senior internal and external stakeholders on project and product matters
- Proven ability to manage global projects, lead and motivate teams, and maintain professionalism in challenging situations
- Strong interpersonal, verbal, and written communication skills, particularly with senior management
- Generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental/company vision.
- Skilled in operating in multi-cultural environments and across global geographies
- Expertise in root cause analysis, risk management, and risk assessment
- Ability to independently analyze data, identify risks, propose corrective actions, and develop innovative solutions through extensive quality experience.

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

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