Lead and continuously improve the GMP self-inspection program, including annual planning and execution Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness Perform gap assessments on global procedures and drive alignment across site functions Coordinate cross-functional activities and ensure effective communication with all departments Support internal, external, and mock audit preparation, including document review and QA input Act as backroom/ACC or scribe team member during audits and inspections Serve as Data Integrity Champion and ensure consistent DI implementation across the site Prepare and present compliance topics to the Quality Council and site leadership Support continuous improvement initiatives and coordinate operational activities within the compliance team Act as back-up for the Quality Compliance & Systems Expert when required University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline Solid experience in biotechnology and/or pharmaceutical industry Strong knowledge of GMP requirements and Quality Systems Understanding of manufacturing, QC laboratory, and warehouse processes for biological products Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles Experience supporting audits and regulatory inspections Skilled in writing, reviewing, and updating SOPs and technical documentation Familiarity with risk management tools (FMEA, RCA, etc.)
Strategic new role to accelerate AI adoption across development, operations, and delivery Acts as the technical AI coach for engineering and DevOps teams Designs and implements AI integration concepts within DevOps workflows Guides teams on how AI enhances CI/CD pipelines, Git workflows, code reviews, and security Builds prototypes and reference implementations for AI assisted pipelines and intelligent automation Supports integration of AI tools into continuous delivery and operational processes Advises on cloud-based AI delivery (AWS, Azure, etc.)
Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards. Mentor and coach colleagues as required including the delivery of training materials as required. Qualifications Bachelor's Degree Related field OR 5-year relevant sponsor or clinical research organization clinical site contracting experienceGood negotiating and communication skills with ability to challenge.Strong legal, financial and/or technical writing skills.Strong understanding of regulated clinical trial environment and knowledge of drug development process.Good understanding of clinical trial contract management.Fluent in English and German language IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Strategic new role to accelerate AI adoption across development, operations, and delivery Acts as the technical AI coach for engineering and DevOps teams Designs and implements AI integration concepts within DevOps workflows Guides teams on how AI enhances CI/CD pipelines, Git workflows, code reviews, and security Builds prototypes and reference implementations for AI assisted pipelines and intelligent automation Supports integration of AI tools into continuous delivery and operational processes Advises on cloud-based AI delivery (AWS, Azure, etc.)
Je zorgt voor correcte werkstructies- en processen. Uiteraard ben je er als vraagbaak en coach voor je team en zorg je ervoor dat iedereen goed in zijn vel zit en optimaal presteert (POP). Ook ben je verantwoordelijk voor alle hr gerelateerde zaken als verzuim, werving en selectie en beoordeling.
Belangrijkste aandachtsgebieden Medewerkers aansturen en ontwikkelen: je bent een coach met visie en in staat om de richting waarin de organisatie naar toe wil op een aansprekende manier over te brengenTerminal plan opstellen en realiseren: het organiseren en realiseren van financiële en operationele doelstellingenHet waarborgen van consistente kwaliteit en servicegraad Profiel en functie-eisen Jij bent iemand die zich op korte termijn zou kunnen ontwikkelen naar de rol van Terminal Manager.
Background & experience • MSc or PhD in Chemical Engineering, Materials Science, Chemistry or a related field • 7+ years of experience in chemical and/or polymer manufacturing • Solid experience with solid propellants, energetic materials, composites and/or defence/aerospace materials (must have) • Proven track record in scale-up from lab to industrial production, including definition of process windows and critical parameters • Experience managing or leading an analytical laboratory and working closely with QC/QA • Familiarity with ISO / AQAP / defence quality systems and safety regulations for hazardous substances • Experience with SPC, root-cause analysis tools (5 Whys, Fishbone, FMEA) and data-driven process improvements • Working knowledge of MES/ERP systems and process data management is an advantage Personal competencies • High level of precision, accountability, and safety awareness – you do not compromise on quality or HSE • Clear, structured communicator who can translate complex chemistry and data into practical decisions for production teams and management • Strong people leadership skills – able to set direction, coach and develop specialists and technicians, and create engagement in a multicultural environment • Emotionally resilient and comfortable working in a fast-paced, scale-up setting with changing priorities • Curious, proactive, and solution-oriented, with a genuine interest in both technology and its real-world impact At FPRT, you will join at a pivotal moment, where you can directly influence how processes, standards and culture are shaped in Denmark.
Background & experience • MSc or PhD in Chemical Engineering, Materials Science, Chemistry or a related field • 7+ years of experience in chemical and/or polymer manufacturing • Solid experience with solid propellants, energetic materials, composites and/or defence/aerospace materials (must have) • Proven track record in scale-up from lab to industrial production, including definition of process windows and critical parameters • Experience managing or leading an analytical laboratory and working closely with QC/QA • Familiarity with ISO / AQAP / defence quality systems and safety regulations for hazardous substances • Experience with SPC, root-cause analysis tools (5 Whys, Fishbone, FMEA) and data-driven process improvements • Working knowledge of MES/ERP systems and process data management is an advantage Personal competencies • High level of precision, accountability, and safety awareness – you do not compromise on quality or HSE • Clear, structured communicator who can translate complex chemistry and data into practical decisions for production teams and management • Strong people leadership skills – able to set direction, coach and develop specialists and technicians, and create engagement in a multicultural environment • Emotionally resilient and comfortable working in a fast-paced, scale-up setting with changing priorities • Curious, proactive, and solution-oriented, with a genuine interest in both technology and its real-world impact At FPRT, you will join at a pivotal moment, where you can directly influence how processes, standards and culture are shaped in Denmark.