Are you looking for a leadership challenge in Quality Assurance for a leading life science technology company? We got a great Head of Quality role come up in London with a great, growing company. You will need to understand regualtions such as ICH GCP, CFR 21 and ISO practises,a mongst others, as well as lead a small team to develop the company's QMS and QA systems. As this is commercial organisation, client focus and great communication and commercial skills are helpful too 

Purpose of the role:

Responsible for providing GCP and regulatory expertise to our client via definition and management of the Quality Management System (QMS) and Quality Assurance System, for client audits and regulatory inspections.

Responsible for management of the company's quality standards, systems and processes to ensure an environment that is compliant with the requirements of ICH-GCP and clinical trials regulation along with the company's ISO accreditations. Ensuring that the Company's Policies and Procedures are fit for purpose, that systems are in place to respond to CAPA's in a timely manner.

Essential Duties and Responsibilities:

Take ownership, develop and maintain and continually improve business processes and procedures.

To ensure quality compliance against Good Clinical Practice (GCP), clinical trials regulations and MDD/MDR expectations; e.g., EU Directives/Regulations, CFR 21 Parts 11 and 312, along with guidelines and other applicable external legislation and standards e.g., ISO 13485, ISO 14971, MDR 2017/745, ISO 27001, and Data Protection legislation (e.g. GDPR).

Provide regulatory expertise, guidance and training for the company.

Implementation and maintenance of all aspects of the Quality System and SOP life cycle including (but not limited to) process development, review, implementation, training, monitoring of process compliance e.g., via evaluation of SOP deviations, revision and decommissioning of SOPs.

Implementation and maintenance of the QA and Compliance Strategy including (but not limited to);

Defining, maintaining and periodically reviewing the strategy for effectiveness.

Take ownership of the internal and key suppliers auditing schedule and process.

Host and manage audits by potential and on-going customers and regulatory inspections (including but not limited to MHRA and FDA).

Manage the internal audit programme and perform required audits.

Support implementation and oversight of Corrective Actions and / or Preventive Actions and other issues that may impact quality & compliance.

Identify those areas of quality processes that need to be improved and propose new ways to improve quality

Ensuring that the quality system is established, implemented, maintained and monitored in accordance with relevant standards.

Monthly reporting to senior management of quality and regulatory metrics and issues; e.g., non-conformities and progress in resolving these through monthly reporting.

Working with Technical, R&D and Operations staff to review, update and approve policies, procedures, work instructions and forms relating to all aspects of the software life cycle; act as the Subject Matter Expert (SME) for Computer System/Software Validation requirements; review and approve for Quality applicable software development & validation documentation.

Promote the development of a science and risk-based compliance focused culture, ensuring product and service quality in line with the company's values

Develop and administer the Risk Management System (ISO31000 & ISO14971) and coordinate risk reviews and escalations to leadership

Acting as the Management Representative for the Management System with the leadership

Knowledge, Skills and Experience Required for the Role:

Science degree.

Extensive experience as a quality professional in the pharmaceutical/medical device regulatory environment, and has held Quality / Regulatory positions for a minimum of ten years.

Experience within both large pharmaceutical companies and CROs is desirable.

Extensive experience of definition and maintenance of Quality Management Systems, audit planning and management and the clinical trials process.

Excellent understanding of GCP and clinical trials regulation and compliance requirements.

Experience of ISO Quality Management Systems.

Knowledge of international Information Security / Privacy requirements (GDPR, ISO27001, HIPPA etc).

Experience of software validation (e.g. GAMP/Annex 11) gained within a regulated industry i.e. pharmace