CSO Compliance Specialist

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We are looking for a CSO Compliance Specialist to join us in our organization based inBraine-l’Alleud, Belgium.

About the role:

As CSO Compliance Specialist, you will oversee the GMP activities taking place in Clinical Supply Operation. In collaboration with Development & Clinical Supply Compliance and QA teams, you will play a key role to ensure the implementation of QMS and of the related processes and governance within CSO’s organization.

You will facilitate and supports a compliance culture and teams, cross-functionally within the CSO, to:

• Ensure a compliant environment in our Clinical Supply Operations Plant
• Deliver compliant, high-quality IMPs through agile, qualified and trained teams
• Strive for compliance, efficiency and process optimization
• Contribute to the operational activities by performing GMP-related tasks, as required.

GMP activities in scope of the CSO unit:

• Scheduling & Procurement
• Labeling, Packaging, Warehousing & Distribution
• Technical: building/premises, equipments, environment…

The goal of this function is to effectively support UCB development portfolio by providing quality clinical trial materials on-time, in a GMP-compliant facility and always inspection-ready.

What you will do:

• You will drive and promote a continuous quality and compliance mindset within Clinical Supply Operations, ensuring compliance with cGMP’s and UCB’s Quality Management System
• You will partner with DCS Compliance Team and management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system in CSO. Ensure close interface with QA, DCS Compliance and CSO teams.
• You will coordinate and/or participate in the implementation of new regulatory standards within CSO processes.
• You will represent the interests of the CSO teams, serve in multidisciplinary Compliance project teams, working closely with other team members in a cooperative way to ensure project progression
• You will coordinate and/or conduct Quality Standards Gap analysis for the CSO processes, risk assessment, develop remediation plan and manage tasks to completion.
• You will consult and guide the teams in establishment of controls to mitigate compliance risk;
• You will oversee the CSO GMP activities and ensure all employees understand and follow all standard operating procedures.
• You will work collaboratively with managers and staff throughout the CSO organization to provide training, education and promote awareness of and help resolve regulatory and other applicable standards.
• You will assist management in the coordination/management of training plans & matrix and ensure compliance with staff qualification standard.
• You will participate in the development and implementation of compliance training for all CSO staff members.
• You will provide compliance mentorship and coaching to staff within the CSO team

For this position you’ll need the following education, experience and skills:

• You have an excellent understanding in GMP related environment : at least 5 years of experience in the pharmaceutical industry in the field of Manufacturing or Quality.
• You have experience in dealing with with eCMS, Deviations and investigations.
• You have a proven and recognized technical expertise in a field of GMP Manufacturing (eg. environment monitoring, equipments qualif/valid., building management...).
• You have a pragmatic mindset, able to propose workable operational solutions complying to regulations
• You can consider the balance between efforts, risks and benefits when resolving challenges.
• You have a proven ability to provide guidance for improvements and corrective and preventive actions related to quality management system processes
• You are highly organized with attention to detail.
• You have the ability to manage multiple projects/initiatives/tasks and balance priorities.
• You have the ability to balance routine tasks Vs ad hoc tasks, switch execution based on specific needs or circumstances.
• You are proactive, self-motivated and autonomous working style and able to manage own activities under minimal supervision/guidance.
• You have excellent interpersonal, verbal, and written communication skills required, with ability able to convey information in a clear and concise manner to write clear instructions, protocol and reports​.
• You have the ability to lead team discussions and facilitate meetings.
• You openly share information with team and management.
• You can demonstrated ability to collaborate effectively across teams within and beyond own department
• You have an excellent Team spirit.
• You are able to cope with stressful situations
• You are fluent in French and English.