Novo Nordisk Process Manager for all filling sites- Compliance - Audit and inspection inputs- Improvement- Trending- Expansion

Director for Adjuvant Manufacturing, Solutions Preparation , Domestic Cleaning and Manufacturing Facility Compliance.

Responsibilities:• Department management for adjuvant production for the COVID-19 vaccine.• Start new production in new facilities and equipment.• Create an organization and structure for new employees and their process.• Safty and environment manager for the entire department. • Data collection and prioritized tasks and projects.• Management of 37 employees together with 3 managers and there teams.• Daily management through board meetings, rootcause and project management meetings.• Development of teams, employees and processes.• Ensure and improve quality in relation to internal and regulatory requirements.

Responsibilities:• Ensured stable production in 20 year old facilities and production equipment.• Security manager for the entire department and the finished product store• Data collection and prioritized tasks and projects.• Management of 32 employees across 3 teams and administrative• Daily management through board meetings, rootcause and project management meetings.• Development of teams, employees and processes.• Ensure and improve quality in relation to internal and regulatory requirementsResults:• Raised production from a target of 18 million units to 23 million through process improvements and change management.• Sick leave below 3,5% and turnover of 0% in 2019-2020• Managed to move a production that has not focused on optimizations for 20 years. Has improved productivity, quality, equipment and competence.• Has positive result with focus on social well-being and team development• Stable production. Reached over my CPI and Bonus Goals.• Successful DMA audits and inspections, without critical observations.• BlackBird implementation.

Responsibilities:• Ensured a stable production in worn facilities and rundown production equipment• Carried out GAP analyses and prioritised tasks and projects• Built an efficient team from scratch• When I took on this responsibility, there was only one competence employee in the team, the rest were recruited• Management of 6 chemists (specialists) and 5 production technicians• Daily management via whiteboard meetings, root cause and project management meetings• Development of the team, employees and processes• Ensure quality in accordance with internal and regulatory requirements Results:• Great progress in compliance upgrade of facilities, equipment and processes• Reduced deviances. Made many remedial actions and validated a great deal of equipment • Created a team in constant development in terms of productivity, quality and competence• Positive results due to focus on social well-being, team development and training• Stabile production. Reached KPI and bonus targets• Successful FDA and DMA audits, without warning letters

Responsibilities:• Management of 21 operators and technicians in API, formulation, filling, washing and sterilisation, as well as visual inspection.• Optimising production through training and improvement of personnel, equipment and processes• Ensuring quality internal and regulatory requirements, including active participation in internal and external Audit• LEAN management and maintenance of continuous improvement• Goal setting and performance managementResults: • Very stable team with low employee turnover and low absence levels• A good performance culture where employees were motivated to contribute to improvements• A release of one month of production time • Elimination of manual processing – improvement of capacity and productivity• A backorder to subsidiaries of only 0,2%• Reduction of deviances and a marked improvement in routine environment in a classified area (via LEAN)• Successful installation of new process equipment while maintaining deliveries• Successful FDA and DMA audits, without warning letters• 100% reduction in turnaround time

Responsibilities:• Management of up to 26 operators (skilled / unskilled)• 1 – 5 production lines• Develop and train in goals and GMP• Goal setting and performance management• LEAN implementation; management, SMED, KAIZEN, systematic problem solving• Cost, product flow, productivity and quality• Technical, GMP and personnel projects• Project management of small projects (2* star)• Teambuilding, employee appraisal and development, and skills development• Machine responsibility including purchase, maintenance and classificationResults:• Twice the amount of OEE with the same number of staff. 600 million units to 120 million.• SMED reduced by more than half • Successful implementation of continuous improvement/LEAN• Highly motivated and committed team• Reduction of equipment down time• Increase in machine skills and responsibility. Operator trained in maintenance and calibration

Responsibilities: • Management of up to 20 operators• 5 production lines• Development and training in goals and GMP• Goal setting• Product flow, productivity, quality and employees’ own goals• Technical, GMP and personnel projects• Teambuilding and training• Deviance documentation• Handling of complaints / claims • Drawing up and updating SOP• Follow-up of health and safety at work legislation • Machine responsibility including purchase, maintenance and classificationResults:• High delivery reliability• SAP implementation• Purchase and operation of new tablet packaging line (project and validation)

• Daily management of production and packaging. Ensure that all actions related to production is carried out in accordance to applicable instructions• Ensure that safety regulations are complied with• Maintence of cleaning and hygiene in production facilities• Ensure that relevant SOP’s and protocols exist and are adhered to. Draw up new SOP’s.• Ensure that validation and calibration frequencies are complied with• Ensure accordance with GMP and other regulations

• Handling of complaints / claims • Maintenance of production equipment• Follow-up on calculations• Ensure maximal hygiene and order• Machine responsibility including purchase, maintenance and classification