Head of Operations/Infrastructure/Quality

Our client was founded by a core team of innovators and pioneers to build something to truly transform clinical trials to be more modern, efficient and patient-centric.

Thus, the platform they designed has since been received with great enthusiasm in the industry.

Today, the platform is already transforming clinical trials and in use in studies ranging from very small (50 patients) to very large (10,000+ patients).
Adopted by several organizations, ranging from patient recruitment companies and research institutions to several top 10 pharmaceutical companies.

Direct the internal operational activities of the organisation in accordance with policies, goals, and objectives established by the Chief Executive Officer and the Board of Directors.

Manage the infrastructure team operation, delivery, and change management processes.
Lead and interpret QA/Compliance requirements for all company products and services.

Have a look at this snapshot of what you will be doing:
Ops

• Participates in the development and preparation of budgets based upon broad organisation goals and objectives.
• Directs internal operations to achieve budgeted results and other financial criteria. Ensures effective internal controls established and compliant with relevant regulatory legislation for financial and tax reporting.
• Directs the development and installation of procedures and controls, to promote communication and adequate information flow, and thereby solidify management control and direction of the enterprise.
• Develop supplier relationships and manage supplier contracts as per policy.

Infrastructure

• Responsible for the planning and management of the infrastructure team
• Implement infrastructure performance monitoring and continuous improvement programs
• Manage change control process for application inventory and infrastructure components.
• Provide technical leadership and project management of infrastructure service provider and changes required for support of application delivery.

QA/Compliance

• Establish, improve, measure and report quality methodology and processes for all products and services.
• Maintain an expert level of knowledge relative to Quality standards and best practices, as well as Regulatory and ?Privacy Compliance.
• Work closely with other departments to ensure that all phases of the software development life cycle are meeting or exceeding the requirements and quality standards.
• Perform System Assessments including GxP applicability, 21 CFR Part 11, IT security and data protection.
• Quality technical review regarding IT standards and industry standards for Clinical Studies.
• Lead or contribute to root cause investigations, risk and quality/regulatory assessment of non-conformities and CAPAs.
• Interprets worldwide GxP regulations and guidelines and provides strategic and tactical guidance to all impacted functions/roles regarding activities required to maintain regulatory compliance.
• Audits - Plan, establish, implement and maintain an Audit Programme for internal functions and external suppliers (GxP, Privacy, QA, IT Security).
• Ensure the training program of the company and the training records are maintained in compliance with applicable regulatory requirements.
• Support preparation of the compliance documentation (IT / Information Security / Data Privacy) for clinical study submissions (EC/IRB, Regulatory, Data Protection).

Qualifications
Bachelor degree (or higher) in Life Sciences, Computer Science, or other scientific or technical field.

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

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