With a background in regulated industries such as life science and the fertility business (e.g. European Sperm Bank), I have a long-standing experience with respect to quality management, quality management systems, product quality, patient safety, regulatory affairs, best practices and compliance (pharmaceutical drugs, pharmacovigilance, medical devices, clinical trials, tissues and cells, assisted reproduction, data protection/GDPR, patient rights, healthcare professionals’ duties/rights, authorization, record keeping, reporting obligations etc.).
Quality Management helps an organization achieve greater consistency in tasks and activities, involved in the production of products and services. It increases efficiency in processes, reduces wastage, and improves the use of time and other resources. It enables an organization to market their business effectively, exploit new markets and to continuously improve their products, processes, and systems.
At its core, quality management is a business philosophy that champions the idea, that the long-term success of a company comes from customer satisfaction and loyalty. An approach I very much agree with.
I am used to documenting, monitoring and supervising all phases of a product’s or service’ life cycle, and take pride in promoting a culture, that delivers value by fulfilling the needs and expectations of customers and other interested parties.
With a commercial mindset, a passion for creating the best possible product and user experience, and an understanding of the importance of having a 360-degree overview of the challenges and opportunities affecting compliance levels and the client, LHR Consult hereby offers the following services:
- Providing professional expertise and guidance on quality planning, quality assurance, quality control and quality improvement (EU/GxP, ICH, WHO, ISO 900X etc.).
- Acting as Quality Responsible/quality point of contact.
- Mapping of data/dataflows, systems, processes, responsibilities, risks, quality controls and -indicators etc.
- Defining and deployment of a data quality/data governance framework (securing confidentiality, integrity, availability etc.), to ensure better data analytics, decision making, operations support and mitigate ambiguity and misuse (ISO 8000).
- Planning, implementing and driving the processes of risk management, including identification, performing qualitative/quantitative analyses and risk reports, monitoring and controlling – and proactively developing risk mitigation actions (EU/GxP, ICH, ISO 27005/31000).
- Preparing, implementing, operating and continually improving quality management systems/documentation within all aspects of regulatory compliance, e.g. contingency plan, quality manual, policies and SOPs (EU/GxP, ICH, WHO, ISO 900X etc.).
- Setting up and driving electronic document management systems (EDMS) for managing the creation, organizing, filing and accessing, using, sharing, controlling and securing etc. of company documents.
- Determining, measuring, analyzing, evaluating and monitoring of metrics and key/quality indicators (KPIs) to demonstrate performance.
- Management of integrated business processes across the supply chain (supply chain management).
- Identifying and managing challenges and opportunities incl. optimizing of processes/systems according to annual compliance schedule, change requests etc. (digitation/automation, integration of controls etc.).
- Ensuring that initial and continuous training programs are implemented and maintained – and providing stakeholders with the required resources, training, awareness activities and authority.
- Preparing, executing and hosting of – and follow up on internal/external audits and government inspections, consolidating compliance with legal/internal requirements (ISO 19011/27007).
- Registrating, assessing and reporting of unintended incidents, adverse reactions, deviations, non-conformities, complaints etc. – incl. root cause analysis, establishing, implementing and evaluating the effect of and corrective/preventive actions (CAPAs), trend analysis etc. (e.g. EU/GxP).
- Preparing, concluding and maintaining of third party agreements/contract management (customers, vendors, affiliates, partners etc.).
- Coordinating and promptly performing any recall operations and approving of returns to saleable stock.
- Providing expertise and guidance on laboratory safety and precautionary measures, e.g. regarding clean room use, air quality (particle/microbial counts etc.), aseptic/sterile production, personal protective equipment, test kits/methods/results, biohazardous waste, liquid nitrogen/gas alert detectors, blood sampling, cleaning, hygiene and sanitation etc. (EU/GxP, OECD, WHO etc.).
- Calibrating, qualifying, monitoring and maintenance of laboratory/cryogenic equipment incl. reviewing and assessing of validation-, service- and inspection reports, certificates of analysis, package inserts, user manuals, accreditations etc. (EU/GxP, OECD, WHO).
- Preparing of other corporate/staff documentation (e.g. code of conduct/ethics, terms & conditions, confidentiality agreement, staff handbook, job description and introduction plan).
- Facilitation of change processes from idea to concept (design thinking, user involvement, etc.).
- Project management, improvement and oversight to ensure compliance to codes, standards, legal requirements, equipment specifications etc. (e.g. ISO 21500/10006).
- Providing professional expertise and guidance on health-/drug law, best practice/guidelines, standards etc. (e.g. DPSA, DMA, HFEA, BGV, EU/GxP, ICH, FDA/21 CFR, WHO, ISO).
- Liaising with regulatory authorities – related to registrations, applications, reporting, legal requirements etc. (e.g. DPSA, DMA, SSI, NVK).