Quality Systems Manager

The Quality Systems Manager will manage the design and implementation of the site quality systems. This role will require a person to manage the team up to 13 people, participate in regulatory inspections and to present to Polish and Foreign Health authorities.

• Managing the activities and improvement of the Quality Management Systems (QMS) and electronic Quality Management Systems (eQMS) in the organization,
• Implementation of new Quality Management Systems (QMS) including electronic Quality Management Systems (eQMS),
• Managing the change control, deviations, CAPA’s, audits, complaints,
• Managing the documents for activities in Quality Management Systems,
• Participating in regulatory inspections and external audits from customers,
• Monitoring and training staff and delegating responsibilities to their subordinate managers/supervisors,
• Managing the team up to 13 people (specialists and experts).

• A degree or similar 3rd level education in a scientific or engineering discipline,
• 10+ years of experience in Quality Assurance or Quality control within the pharmaceutical industry,
• Further training in Quality management is considered an advantage for this role but not essential,
• Experience in Quality Systems Management,
• Experience in managing quality using Electronic Quality management systems e.g. TrackWise,
• Experience in change control, deviations, CAPA’s, audits, complaints etc,
• Experience in regulatory inspection participation,
• Experience with external audits from customers,
• Prefer experience in establishment of Quality systems from start-up,
• Document management experience,
• Experience in managing a team,
• English - full professional proficiency, speaking Polish is an advantage.