Global Quality Lead Auditing Technology
il y a 4 semaines
**Make your mark for patients**
To strengthen our **Global Quality Auditing **department we are looking for a talented profile to fill the position of**:Global Quality Lead Auditing Technology** **- Braine l’Alleud, Belgium**
**About the role**
The Global Quality Lead for Auditing Technology develops and implements a risk-based Technology Quality Auditing Strategy, ensuring compliance of the UCB Technology Audit Program with regulatory requirements and UCB's Global Quality Management System. This role ensures technology solutions supporting R&D (GLP/GCP) and PV meet compliance standards and mitigates related risks.
This person will also provides expert input on processes impacted by technology, aligning with global/local regulations and industry best practices, while staying informed of trends through external networks like industry forums and associations.
**You will work with**
This function is requiring close partnerships across various teams. Within the Quality Organization, you’ll work closely with departments such as R&D and PV Quality Management, Quality Systems & Intelligence, Devices and Primary Packaging Quality, and other auditing teams within Global Quality Auditing. Beyond Quality, you’ll engage with stakeholders like IT, Devices Artwork and Packaging, Patient Value Units, and others in R&D and PV. Additionally, you’ll interact with international regulatory authorities during inspections to ensure compliance and quality standards.
**What you will do**
Internal & External Auditing:
- Supports the creation and maintenance of the Global Audit Programs, leveraging a risk-based approach for ranking and prioritization.
- Supports the Global Audit Programs through the execution of Routine audits, Due Diligence Audits, Mock Inspections, For Cause audits and Pre-approval or Routine inspection assistance as assigned per senior management.
- Ensure the follow up on the above-mentioned audits, as well as timely CAPA closure.
- Partner with the UCB Network QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections, as deemed necessary and which may include on-site or remote inspectional support activities.
Drive Insights for UCB through Data:
- Ensure timely and accurate input of audit data in Audit Management Tool.
- Contribute data and feedback to relevant internal stakeholders in UCB (e.g., IT, Device, Packaging & Wearable Tech, PVUs, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
Compliance Issues:
- Partner with colleagues/ others to identify and mitigate Compliance risks, resolve potential regulatory observations,
- Escalate Critical Compliance risks/issues to Quality Auditing & Compliance Leadership.
- Leverage internal resources and SME network to develop appropriate action plans and decisions as needed.
Consulting, Educating, Quality Improvement, and External Focus:
- Provide Technical and Compliance guidance as a member of selected committees,
- Lead improvement initiatives, identified by Senior Management, in-order to improve Corporate QA processes and effectiveness,
- Partner with the UCB Network QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections, as deemed necessary and which may include on-site or remote inspection support activities and/or training,
- Keep abreast of regulatory and industry trends: Share key information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality Standards
**Interested? For this position you’ll need the following education, experience and skills**
- Bachelor’s, master’s degree or an education in a relevant scientific discipline (Computer Science, Bioinformatics, Engineering or related science).
- At least 5 years of experience in a Quality role, preferably as an auditor
- 10+ years of experience in software development, including security, data privacy, integrity assessments, agile methodologies, and software verification and validation.
- 5+ years of experience with In Vitro Diagnostic Medical Devices and Medical Devices, including commercial devices for clinical trials
General
- Strong presentation, training, interpersonal, negotiation, and organizational skills.
- Ability to build internal and external partnerships and prioritize based on compliance and patient safety risks.
- Fluent English communication (oral and written); additional languages are a plus.
- Skilled in audit management tools, document systems, and regulated databases, with strong analytical and investigation capabilities.
- Capable of national and international travel (30% of the time), confident presentation skills, and skilled in negotiation and risk management.
Digital
- Expertise in regulatory requirements for digital systems in R&D, including DHT used in clinical studies.
- Knowledge of statistical principles, programming, and cloud collaboration tools (
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