Job Description

The QA Manager will establish, oversee, and maintain the Quality Management Systems (“QMS”) and Continuous Improvement programs across the company. The core function of the role will be to drive change and provide leadership to develop and maintain quality systems that meet regulatory and statutory requirements (e.g. ISO, EMA and FDA guidelines).
Job Interactions And Interface

The QA Manager will be the key point of contact for auditors representing clients and regulatory bodies, industry organizations, consultants, vendors, and health care professionals.

Responsibilities

• Develop and maintain the QMS including approval of procedures
• Review and update of the QMS
• Quality oversight and audit of activities, including operating procedures and record keeping
• Monitoring and oversight of CAPA effectiveness from internal and external audits
• Liaison with customers for remote assessments and on-site audits
• Supervision of staff
• Generation of quarterly QMS reports for Executive Management
• Implement feedback from Executive Management and corporate parent company regarding the QMS
• Integration of relevant aspects of parent company
• Identify and implement process improvements to ensure more effective program execution

Required Knowledge, Skills, and Abilities

Degree level, or equivalent, in a relevant discipline Ability to clearly communicate to both technical and non-technical audiences Good understanding of the Principles behind Quality Management Systems e.g. ISO 900X or equivalent essential Experience of Computer Systems Validation Minimum 10 Years’ Experience with Quality Engineering