Elverum, Innlandet, Norway
Plan and perform in any case.
-Lead the Quality Control laboratory at Curida, overseeing release testing of finished products, raw materials and packaging components, as well as all stability study analyses. -Manage analytical activities for technology transfer projects, ensuring seamless integration of new products and methods into the QC environment. -Direct end‑to‑end analytical lifecycle management, including method development, method transfer and method validation in compliance with regulatory expectations (ICH, GMP). -Drive Operational Excellence initiatives within the laboratory by optimizing workflows, reducing analytical cycle times and enhancing data integrity and compliance. -Provide technical leadership and guidance to analysts, ensuring high scientific standards, robust documentation practices and continuous improvement in laboratory performance.
-Lead enterprise‑level Operational Excellence and Digital Transformation programs, driving end‑to‑end process redesign, automation and cultural change to elevate organizational performance. -Oversee a portfolio of high‑impact strategic projects, ensuring alignment with business priorities, effective stakeholder management and delivery of measurable operational and financial outcomes. -Establish performance targets and design comprehensive KPI frameworks to monitor efficiency, identify bottlenecks and implement data‑driven improvement strategies across functions. -Champion structured problem‑solving methodologies (Lean, Six Sigma, A3, RCA) to resolve systemic issues, strengthen process robustness and embed continuous improvement mindsets. -Accelerate digitalization by evaluating, implementing and scaling digital tools, analytics platforms and automation solutions that enhance transparency, decision‑making, and operational agility. -Drive cross‑functional collaboration to harmonize processes, standardize best practices and ensure sustainable transformation across manufacturing, quality, supply chain and support functions. -Mentor teams and leaders on OE principles, digital capabilities and performance excellence, fostering a high‑performance culture focused on innovation and continuous improvement.
-Lead the Quality Control organization with 13 direct reports and approximately 150 employees, overseeing end‑to‑end QC operations across 11 specialized laboratories -Ensure full GMP compliance and inspection readiness by strengthening quality systems, enhancing data integrity practices and driving continuous improvement across all QC functions -Manage global and cross‑site QC initiatives within Sanofi’s international network, leading large‑scale projects focused on harmonization, standardization and capability building -Oversee analytical lifecycle management, including method development, method transfer, method validation and troubleshooting for both commercial and development products -Drive Operational Excellence within QC by optimizing workflows, reducing analytical cycle times and implementing Lean‑based problem‑solving methodologies to improve efficiency and reliability -Set performance targets, establish KPI dashboards, and lead performance governance routines to monitor laboratory productivity, resource utilization and quality metrics -Partner with global functions to support product launches, technology transfers, deviation investigations and strategic decision‑making -Develop and mentor QC leaders and experts, -Provide strategic leadership to a large QC organization, ensuring clarity of direction, strong communication and alignment of teams around shared quality and performance objectives -Build and develop high‑performing QC leaders through coaching, succession planning and capability‑building initiatives, strengthening the long‑term talent pipeline of the site -Promoting proactive problem‑solving across QC, QA, Manufacturing and Supply Chain -Lead organizational transformation efforts within QC, including restructuring, role optimization and competency development to support future business needs -Contributing to network‑wide harmonization projects, sharing best practices within Sanogi global and influencing global quality strategies
-Led the Quality Control function with full responsibility for analytical operations, compliance, and laboratory performance, ensuring robust GMP standards across all QC activities including In process control. -Successfully implemented the LIMS system from the ground up, driving digitalization of QC workflows, enhancing data integrity and significantly improving traceability and efficiency. -Managed multiple first‑time EU GMP inspections, achieving strong compliance outcomes and establishing a sustainable inspection‑ready culture within the QC organization. -Oversaw and coordinated audits and regulatory interactions with ANVISA (Brazil), Russia, Ukraine, and other international authorities, ensuring timely responses, corrective actions and alignment with global regulatory expectations. -Directed analytical lifecycle activities including method development, method transfer, method validation and troubleshooting for both commercial and development products. -Strengthened QC governance by establishing performance KPIs, monitoring laboratory productivity and implementing continuous improvement initiatives to optimize analytical turnaround times. -Led cross‑functional collaboration with QA, Production, Supply Chain and R&D to support product releases, deviations, investigations and technology transfer activities. -Built and developed a high‑performing QC team, fostering scientific excellence, accountability and a culture of continuous improvement.
-Supported the strategic leadership of the QC organization, coordinating day‑to‑day laboratory operations and ensuring seamless collaboration across analytical, microbiology, raw material and stability teams. -Managed and developed a diverse team of analysts and supervisors, strengthening communication channels, coaching talent and fostering a culture of accountability, scientific rigor and teamwork. -Played a key role in the digitalization of QC processes, contributing to the rollout of electronic documentation systems, data integrity enhancements and early-stage centralization initiatives. -Led cross‑functional coordination with QA, Production, Supply Chain and R&D to resolve quality issues, accelerate decision‑making and maintain uninterrupted product release flow. -Oversaw method lifecycle activities, including troubleshooting, method optimization and analytical harmonization efforts across multiple product lines. -Drove continuous improvement actions by identifying operational bottlenecks, standardizing workflows and implementing practical solutions that improved efficiency and reduced turnaround times. -Actively contributed to audit readiness and regulatory compliance, supporting successful inspections and ensuring alignment with GMP expectations and internal quality standards
-Lead the preparation of Annual Stability Reports in alignment with established timelines and regulatory requirements. -Compile, analyze, and interpret analytical and regulatory data to generate accurate and meaningful insights. -Evaluate real-time stability data and statistical reports to support data-driven decision-making. -Ensure full compliance with established testing procedures and quality standards. -Collaborate with Drug Regulatory Affairs to support timely submission of stability reports to the FDA. -Provide stability data and reports to support product lifecycle activities, including compliance investigations, product transfers, divestitures, and validation studies. -Manage stability data processes and provide guidance and oversight for Annual Stability Report preparation. -Contribute to cross-functional project teams to support assigned organizational initiatives. -Develop, review, and maintain Standard Operating Procedures (SOPs) in compliance with regulatory expectations. -Maintain accurate and compliant documentation and archiving of Annual Stability Reports. -Ensure stability reports contain scientifically sound conclusions to support shelf-life assignment, storage conditions, packaging, and transportation requirements.
-Coordinated the full stability program lifecycle, including creation of annual stability plans, protocol preparation, sample allocation strategies and cross‑functional alignment with QA, Production and Supply Chain. -Managed end‑to‑end stability sample handling: collection from production batches, GMP‑compliant labeling, documentation and placement into qualified stability chambers under ICH conditions. -Executed stability testing according to validated analytical methods, ensuring timely completion of analyses, accurate data entry and adherence to data integrity principles. -Prepared stability reports and trend evaluations, supporting product lifecycle management, regulatory submissions and global quality assessments. -Oversaw routine maintenance, calibration and qualification activities for stability chambers and laboratory equipment, ensuring continuous compliance and uninterrupted study execution. -Contributed to digitalization initiatives by improving documentation workflows, enhancing traceability and supporting early LIMS integration efforts within the QC environment. -Collaborated in a global Novartis network, participating in cross‑site discussions, harmonization projects and knowledge‑sharing activities to align stability practices with global standards. -Supported internal and external audits by providing stability documentation, responding to queries and ensuring readiness for regulatory inspections.