Global Quality Lead Gvp Audit Compliance
il y a 2 semaines
**Make your mark for patients**
To strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Global Quality Lead GVP Auditing & Compliance based in Braine l’Alleud, Belgium
At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.
You like to work in an environment where you will:
- Lead and/or participate in the development of the risk based PV audit program through evaluation of elements of the UCB clinical safety and Pharmacovigilance quality system and their effect on the overall state of compliance of the system.
- Deliver the Pharmacovigilance audit program (including audits of Critical Processes, Affiliates, Licensing Partners, Service Providers/Vendors) in support of clinical safety and Pharmacovigilance activities related to UCB products.
- Perform PV audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
- Perform due diligence PV audits of potential company or asset acquisitions, as required.
- Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
- Lead the preparation, hosting and follow up of Regulatory Authority inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and Affiliates as deemed necessary and practicable.
- Manage external auditors and/or vendors as required, ensuring that findings from audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the audit management tool.
- Ensure timely and accurate input of audit and inspection data in Audit Management Tool.
- As required and in collaboration with Quality Auditing Specialists, issue KPIs and dashboards that allow proper identification, follow-up and review of trends; providing a comprehensive summary and analyses of the comparative risks and outcomes across the PV quality system
- Contribute data and feedback to GVP-relevant internal stakeholders in UCB (e.g. Patient Safety & Medical Management, Global Regulatory Affairs, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
- Through active participation on the PV Quality Council and through direct interaction with colleagues, escalate concerns and provide expert guidance on PV compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
- Escalate Critical Compliance risks/issues to Quality Auditing & Compliance Leadership.
- 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, GVP, other applicable regulatory requirements and UCB global quality standards
- Participate in medium-long term projects within competence.
- Lead improvement initiatives, and where relevant, create and own the supporting UCB Policies and standards, oversee their deployment including training material development, periodic review by senior management, as well as their maintenance by leveraging the Regulatory Surveillance process and industry benchmarking.
- 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).
Interested? For this position you’ll need the following education, experience and skills:
- Minimum of 5 years auditing, 5 years Pharmacovigilance and/or a combination of the two.
- Familiarity with statistical principles and data analysis.
- 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 integrity with a strong commitment to patient welfare and ethical behavior.
- Fluent in written and spoken English. Additional language skills would be an advantage.
- Able to travel nationally and internationally as business necessitates, 30% of time on average.
- Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and
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