Quality management

With a solid background in regulated industries in the healthcare sector (pharma and tissues & cells/assisted reproduction), I have a long-standing experience with product quality, patient/consumer safety, business ethics and scientific research.

As Quality Manager in the fertility industry 2012 – 2020, I developed, imple-mented and maintained the organizational quality management system, effectively meeting customer expectations and applicable regulatory requirements, guidelines etc. (ISO 900X, GxP, ICH, OECD, WHO etc.).

The framework helped the organization achieve greater consistency and efficiency in processes, market itself more effectively, exploit new markets and continuously improve products and services. Along the way, it established itself as brand-leading in Europe, and a pionering player on the global fertility market.

In 2021, I launched my own consultancy, and has since helped clients with various quality-related tasks.

Dealing with many types of products and services, dynamic and complex business processes – and having to collaborate with- and coordinate between many stakeholders (employees, consumers/patients, donors, clinics, healthcare professionals, service providers, regulatory authorities etc.), I have an extensive practical experience with all aspects of quality management, and a deep understanding of the underlying requirements.

I hold a number of certificates in quality-, risk- and project management (ISO 9001, 31000 etc.), GxP, auditing, business continuity (ISO 22301) etc., and I am used to acting as the subject matter expert, providing legal advise, training and authority, leading projects and work groups – and having the grand overview of quality related activities.

Based on this, LHR Consult offers the following services:

Mapping of processes (input/output), systems, indicators/controls and require-ments for local and global markets etc. (GxP, ICH, OECD, WHO mv.).
Implementing of a quality framework, quality management principles and -concepts (”Plan-Do-Check-Act” cyclus, risk-based approach etc.).
Aligning the quality program with the organizational culture, needs of stakeholders and the broader business objectives and goals – ensuring flexibility in order to incorporate legal, market and business requirements.
Performing gap analyses against current frameworks/legal requirements.
Risk management of all business areas incl. identification and implementation of relevant physical, administrative and technical security controls to ensure continued confidentiality, integrity, availability and robustness of treatment systems and services (ISO 31000, ICH/FMEA, etc.).

Establishing responsibilities, reporting structures and communication with internal/external stakeholders to ingrain organizational accountability.
Liaising and sparring with national/international supervisory authorities (registration, application, hearing, reporting, complaints, inspection, scientific research etc.).
Establishing, monitoring and analyzing metrics (KPIs etc.) for oversight and governance, regarding trending, return on investment (ROI), business resiliency, program maturity etc.
Developing organizational quality policies, operating procedures and templates, e.g. regarding inquiries/complaints, deviations/corrective actions, design and development, identification and traceability, change control, post-delivery activities, incident responses, business continuity/disaster recovery, vendor management and code of conduct.
Preparing, concluding and maintaining of contracts/agreements with affiliates, partners, vendors, customers etc.
Preparing, implementing and operating of a document management system (e.g. acquisition of an EDMS).
Anchoring and sustaining a strong business ethics mindset (machine learning/ artificial intelligence, biometrics, genetic screening, whistleblowing, clinical research, pharmacovigilance, scientific research etc.).
Providing training and awareness activities for employees, partners, vendors etc. (quality, safety, information-, IT- and cyber security, business ethics etc.).
Management of integrated business processes across the supply chain (supply chain management).
Preparing, executing, reporting of – and follow up on internal/vendor auditing.
Preparing and hosting of – and follow up on government inspections and external auditing, consolidating compliance with legal/internal requirements.
Managing deviations/non-conformities and complaints related to business processes, products and services – incl. root cause analysis, trend analysis, implementing corrective actions etc. (GxP etc.).
Managing unexpected incidents related to business processes, products and services (GxP etc.).
Identifying and managing challenges and opportunities to continuously improve the quality program (digitation, automation, cloud, further development of IT solutions etc.).

Services related to life science/healthcare and data protection may well be combined with those mentioned above. For more information – see relevant sub-menus under “Services”.