Global Quality Lead GVP Audit Compliance

工作内容

Make your mark for patientsTo 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, BelgiumAt 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.
• In-depth knowledge and understanding of international Pharmacovigilance regulations, quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations.
• 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 willingness to accept responsibility.
• Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with external inspectors and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
• Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.
• Ability to proactively identify, assess, mitigate and manage potential risks to add value for patients and maintain UCB’s reputation.
• Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.
• Ability to cope with stressful situations and drive issue resolution and decisions.
• Excellent planning and organizational skills. Structured approach.
• Ability to build partnerships internally and externally.
• Ability to navigate in the grey zone with the right sense of risk appetite, smart risk-taking behaviors and values
• Ability to apply change management principles and practices, to promote an environment of effective people engagement and efficient transition/adoption of changes

Why you should applyWe can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.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 UsUCB 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 for us?At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.