Main Accountabilities
Ø Compliance
· Developing, implementing, and maintaining an effective compliance program
· Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry
· Maintaining a system to ensure compliance and quality risks are properly identified, tracked, and mitigated
· Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance
· Provide training and guidance to employees on compliance topics from global Sanofi standards applicable for the site
· Coordinating and managing regulatory inspections and audits from external bodies
· Identifying compliance risks and contributing to the development of strategies to mitigate them
· Collaborating with other departments, such as legal and P&C, to manage compliance issues
· Ensuring any compliance incidents are properly reported and investigated with the implementation of appropriate corrective actions
· Overseeing the maintenance and management of compliance-related documentation
· Identifying and leading continuous improvement initiatives to enhance the compliance with appropriate health regulations
· Is or host the Business Owners for Risk management, quality alerts
· Leading and managing the compliance team, including hiring, training, coaching, professional development, and performance evaluation
Ø Quality Risk Management
· Ensuring the appropriate global harmonized methodology (incl. tool) is followed to assess and document quality risks
· Reviewing periodically the ongoing quality risks with risk owner and risk leader to reassess their control level in collaboration with Site Risk Officer
· Maintaining a living risk library and ensuring periodic review process is done
· Monitoring and reviewing risks metrics to ensure continuous improvement in quality risk management process
· Collaborating with other groups and functions for the appropriate use and implementation of the Quality risk management methodology (e.g., deviation, complaints)
· Providing support during regulatory inspections and audits by presenting the necessary documentation and responses
· Representing the site in the quality risk management (QRM) CoP led by global and ensuring local communication. If requested, participating in the CoE.
· Developing and delivering training programs principles and practices.
· Ensuring that all risk assessments are conducted with trained facilitators
Ø Business owner
· Being the Business Owner of a given quality process for the site. Owning process, system, and data
· Conducting regular routine data quality checks and validations to identify and address any process, system, or data issue
· Developing and delivering training programs principles and practices
· Identifying and assessing risks related to the process in scope and implementing mitigation strategies
· Leading continuous improvement initiatives on site, in line with global processes and practices
· Overseeing the computerized systems associated with the process to ensure they meet all requirements
· Establishing and monitoring key performance indicators in line with global guidance
· Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
· Representing Sanofi global quality when interacting with health authorities for global processes
Section 3: Key Involvement in Decision-Making Process
Key Roles (D,A,I)
Ø Compliance Manager
· Support management on compliance topics (A)
· Review the relevance of remediation action from findings from internal and external audits related to health-related topics (D)
· Advise on improvements to compliance processes and systems (A)
· Decide on risk mitigation strategies (D)
· Decide on corrective actions for compliance incidents (D)
· Advise on continuous improvement initiatives (A)
· Coordinate quality alert and batch recall process with global team (A)
Ø Quality Risk Management
· Decide on eligibility of quality risk for entry in the risk profile (D)
· Develop and maintain risk matrix/heat map and support management on Quality risk topics (A)
· Advise on quality risk management strategies and improvements (A)
Ø Business owner of Recall and QEE
· Establish and prioritize process evolutions for the site (D)
· Support audit and inspection and present the process to auditors and inspectors (A)
· Proactively identify remediation actions from findings from internal and external audits (A), under control of the global process owner
· Identify training needs (A)
· Is informed of inspections and audits outcome (I)
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