Sanofi
pharmaceutical
M&SHeadofQualitySystem&ComplianceBeijing
“M&S-Head of Quality System & Compliance-Beijing at Sanofi. Skills: Quality System, Compliance, Quality Management System (QMS). Developing, implementing, and maintaining an effective compliance program. Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry”
What You'll Achieve.
Establishing and monitoring key performance indicators (KPIs) and metrics for the site compliance and reporting on the results to management; Establishing and monitoring key performance indicators (KPIs) and metrics for the QMS, and reporting on the QMS performance and effectiveness
Industry & Context.
Managing and resolving any compliance issues or allegations that arise, and taking appropriate corrective and preventive actions; Identifying and driving continuous improvement initiatives and projects to enhance the site compliance, fostering a culture of compliance; Identifying and driving continuous improvement initiatives and projects to enhance the QMS efficiency and effectiveness, leveraging new technologies, tools, and methods as key means and fostering a culture of continuous improvement
What They're Looking For.
Must Have
minimum 5 years management experience in production and /or quality assurance, knowledge of regualed quality systems within the pharmaceutical or related industry, At least a bachelor degree in pharmacy or chemistry or biology disciplines, Fluent English in verbal & written
What You'll Do.
and maintaining an effective compliance program
Ensuring that the site complies with all laws
and standards applicable in the pharmaceutical industry
Maintaining a system to ensure compliance and quality risks are properly identified
Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance
Ensuring that any compliance issues are reported to the relevant authorities in a timely manner
Managing and resolving any compliance issues or allegations that arise
and taking appropriate corrective and preventive actions
Developing and implementing the annual QMS objectives in alignment with the organizational strategy
Ensuring the Quality Management System is at all times compliant with applicable regulatory requirements and company quality standards
Maintaining a system to ensure quality systems are properly identified
Ensuring documentation system is in place and updated on a regular basis
Ensuring the high quality and timely closure of quality events such as deviations
and change controls to maintain compliance and operational efficiency while also keeping quality backlogs under control
Ensuring license to operate training programs are in place to guarantee that all employees have the knowledge and qualifications needed for their tasks
Providing QMS guidance
and training to all staff and stakeholders
and promoting a culture of quality and compliance across the organization
Establishing metrics and monitoring data for the QMS activities to identify trends and issues and to implement action plan
Leading management reviews to assess the effectiveness of the QMS and leading the coordination of all elements of the site management reviews
How You'll Work.
Team & Collaboration
Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters; Leading and managing the compliance team, including hiring, training, coaching, professional development, and performance evaluation; Providing QMS guidance, support, and training to all staff and stakeholders, and promoting a culture of quality and compliance across the organization; Leading and managing the QMS team, including hiring, training, coaching, and performance evaluation
Communication Scope
Good communication and collaboration; Fluent English in verbal & written
Process & Methodology
Identifying and driving continuous improvement initiatives and projects to enhance the site compliance, fostering a culture of compliance, Identifying and driving continuous improvement initiatives and projects to enhance the QMS efficiency and effectiveness, leveraging new technologies, tools, and methods as key means and fostering a culture of continuous improvement
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