Quality Manager

Job Description:

The Quality Manager is responsible for the development, maintenance, and compliance of CSIs Quality Management System.  

Oversight of good compliance practices for operational quality activities of the CSI team and ensuring that all business activities are conducted in accordance with relevant rules, industry and regulatory guidelines associated with the companies WDA and IMP(MIA) licenses. 

The person will take a leading role in the due diligence process, certification, training, and monitoring of employee’s compliance.

Working closely with the Management Team and with other key process owners he/she will be responsible for advising on the potential risks of any activity in accordance with legislation, guidance and company policies.

Will act as the link between Quality and Business functions, taking care of and supporting the implementation and training responsibilities for Quality and Compliance SOPs. 

• Conduct oversight of relevant vendor management activities for Distribution partners who perform GxP activities including qualification, requalification, implementation of quality agreements and audit. 
• Ensure processes for the purchase and delivery of medicinal products are effective and in accordance with the current regulatory requirements. 
• Ensure all CSI employees and Partners involved in the purchase and delivery of product are adequately trained in principles of GDP, GMP
• Ensure internal/external audits are performed at appropriate regular intervals.
• Support regulatory authority inspections with readiness, preparation, coordination and participation.
• Lead and coordinate external audits and perform related follow up and CAPA implementation
• Lead and coordinate the self-inspection program and perform related follow up and CAPA implementation
• Maintain the company’s Site Master File 
• Review and approve of Quality Agreements 
• Develop Quality Management Systems consistent with Industry and regulatory requirements
• Support learning requirements, ensuring the assignment of Core Quality training and management training assignments
• Responsible for internal audit execution, document system maintenance and trainings.
• Generate and approve standard operating procedures and other quality documentation

Required/Preferred Education and Qualifications:

• Bachelor’s degree in in Pharmaceutical or Science discipline as a minimum
• Minimum 5 years’ experience in quality (auditing, quality oversight, QMS) working in pharmaceutical, biotechnology, wholesaler or CRO. 
• Eligible to meet requirements to act as GDP Responsible Person
• Extensive experience acquired in regulated industries (ISO, GMP, GDP, etc.)
• Knowledge and understanding of the regulatory compliance framework/QMS within the EU
• Proven track record in collaboration
• Understanding of commercial business needs and priorities
• Independent thinking and action, as well as the potential to develop and take on increased responsibility.
• Outstanding interpersonal skills and proven ability to communicate and work with all levels of the organization 
• Excellent verbal and written communication skills in English.