Global Quality Lead Auditing Gcp

il y a 4 semaines

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Quality Auditing & Compliance** we are looking for a talented profile to fill the position of**:Global Quality Lead Auditing GCP - Braine l’Alleud, Belgium**

**About the role**

The Global Quality Lead GCP Auditing & Compliance develops and implements a GCP audit strategy, ensuring UCB's clinical trials comply with regulatory requirements, contractual agreements, and UCB's Global Quality Management System. The role identifies and mitigates compliance risks while providing expert input on GCP-related processes, ensuring alignment with global and local regulations and best practices. Additionally, this person stays informed of industry trends through external networks such as industry forums and associations.

**You will work with**

To ensure an effective end-to-end approach, close collaboration is essential across multiple areas. Within the Quality Organization, this includes working with teams such as Early & Development Solutions Quality Management, Quality Systems & Intelligence, and other auditing teams within Quality Auditing & Compliance. Outside of Quality, partnering with stakeholders like Global Clinical Sciences & Operations, Global Clinical Development, and Statistical Science & Innovation is crucial. Additionally, engagement with international regulatory authorities during inspections is necessary to maintain compliance and meet global standards.

**What you will do**

Internal & External Auditing/Inspections
- Lead and contribute to the risk-based GCP audit program, assessing UCB’s quality system and compliance.
- Conduct GCP audits (investigator sites, vendors, systems) as part of the annual audit plan, and for new vendor qualifications or potential acquisitions.
- Manage external audits, ensuring vendors and consultants follow UCB’s processes and standards.
- Oversee audit findings, CAPAs, and support regulatory authority inspections related to clinical activities.

Drive Insights for UCB through Data
- Ensure timely and accurate input of audit data in Audit Management Tool.
- Contribute data and feedback to GCP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, etc.) relating to Key Quality/Performance Indicators and quality compliance status.

Compliance Issues
- Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
- Escalate Critical Compliance risks/issues to Global Quality Auditing Leadership.

Consulting, Educating, Quality Improvement, and External Focus:

- Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and UCB global quality standards
- Participate in medium-long term projects within competence.
- Upon the request of/with the approval of Quality Auditing & Compliance Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications)
- Collaborate with and influence key stakeholders within UCB to collectively drive quality across the organization.

Management and Leadership
- Leads a small team of auditors that plays a key role in supporting audits for UCB's R&D activities.Organize and balance the team to reach the fixed objectives.
- Recruit, build, and partner to provide auditor capabilities in accordance with UCB strategy.
- Foster the development of technical and organizational expertise for the team.

**Interested? For this position you’ll need the following education, experience and skills**
- Bachelor's or Master's degree required, auditor certification and preferred sciences certifications/registrations (e.g., medical, pharmacy, nursing, public health) are a plus.
- Fluent in English (oral and written); additional languages are a plus.
- Minimum of 5 years of auditing experience and overall 10+ years experience dealing with GCP related areas.
- Extensive experience in the pharmaceutical/biotechnology sector, including significant time in GCP-related fields such as Clinical Data Management and/or Biostatistics.
- Experience in clinical trials, especially with Decentralized and/or Hybrid Trials, or Gene Therapy trials, is advantageous.
- In-depth knowledge in data management, data analysis and statistical principles applied to clinical trials.
- Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
- Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
- High level of personal inte

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