compliance specialist 14245.

In collaboration with the Clinical Supply Compliance and QA teams, the CPLO (Clinical Packaging & Logistics Operations) Compliance Specialist plays a key role in ensuring the implementation of the QMS and its related processes and governance within the CPLO organization.

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

The requirement for this position as compliance specialist are : 

• Excellent understanding in GMP related environment : at least 5 years of experience in thepharmaceutical industry in the field of Manufacturing or Quality.
• Proven and recognized expert in the field of GMP Compliance.
• Expert dealing with with eCMS, Deviations and investigations.
• Pragmatic mindset, able to propose workable operational solutions complying to regulations
• Considers the balance between efforts, risks and benefits when resolving challenges.
• Proven ability to provide guidance for improvements and corrective and preventive actions related to quality management system processes
• Highly organized with attention to detail.
• Ability to manage multiple projects/initiatives/tasks and balance priorities.
• Ability to balance routine tasks Vs ad hoc tasks, switch execution based on specific needs or circumstances.