Probi AB

Manager

• Build a high-performing quality team.
• Mentor, coach, train, and lead quality personnel.
• Perform administrative duties such as scheduling, performance reviews, hiring, budget, etc.
• Identify and document risks and gaps applicable regulatory, GMP, GLP, ISO, and/or customer requirements.
• Keeps management informed about risks and critical non-conformities.
• Under guidance from Sr Director Global Quality, assess, recommend and establish an effective Quality Management System governing manufactured products and testing laboratories.
• Establish effective laboratory and quality processes to ensure the proper testing and release procedures are in place, including maintaining effective deviation, OOS, and CAPA systems.
• Ensure that change control, standardization of work, training, deviations, CAPA, complaints, and audits serve organizational quality objectives and priorities.
• Author, revise, and update-controlled documents, such as SOPs, forms, and charts.
• Ensure all requisite quality control activities are executed as specified in a timely manner.
• Oversee routine testing and analysis to maintain accuracy and precision.
• Ensure proper maintenance and calibration of testing equipment.
• Review and approve Master Manufacturing Records and Product Specifications.
• Oversee the review and disposition of materials to ensure they meet specifications.
• Maintain accurate and complete records of all quality and testing activities, ensuring documentation meets regulatory requirements and is readily accessible for audits.
• Preparation of clear concise audit reports that ensure mitigation of identified risks and that appropriate corrective/preventive action plans are implemented to address gaps in systems/processes and/or risks.
• Ensure effective maintenance of Certifications and Standards, including timely responses to findings and opportunities for improvements.
• Manage change controls and variations as appropriate.
• Investigate customer complaints using systematic methods and properly identify root cause and associated corrective and preventive actions.
• Keep current on changes in industry and regulatory standards for GxP requirements and advise on business impact.
• Ensure readiness of all quality activities incl. audits and inspections.
• Influence multiple stakeholders across Quality, Supply Chain and Product Development & Application departments as well as Suppliers and Customers, hence using a pro-active mindset and ability to work with stakeholders to identify and resolve findings with solutions that are fit for purpose and ensure sustained compliance performance.

Quality Manager

Account Manager

• Manage and grow existing business mainly in the DACH / Benelux regions.
• Act as the primary interface between customers and Probi.
• Lead each step of the sales process, from identifying prospective customers to closing deals.
• Establish and nurture relationships with key functions and stakeholders at all levels.
• Conduct on-site sales meetings with customers and prospects.
• Develop short- and medium-term commercial plans in collaboration with sales leadership, marketing, product functions and R&D.
• Complete and maintain accurate reporting of all sales activities in CRM.

Quality Manager

EMEA Account Manager – DACH / Benelux