Global Quality Systems Senior Specialist

Hira Ni; United Kingdom; Remote; GBP 70,000 - 100,000; Full time

Job summary

HIRANI seeks a Global Quality Systems Senior Specialist to shape, implement and maintain electronic Quality Systems across its global Pharma Services network. You will partner with international sites, IS teams and external partners to ensure robust CSV, regulatory compliance and system architecture.

The role involves leading validation, lifecycle activities and audit support to align with GMP/ISO standards and business needs on a global scale.

Qualifications

• Degree (or equivalent) in a Life Science or related discipline.
• Significant experience in a regulated Quality System (GMP, ISO, etc.).
• Strong understanding of pharmaceutical quality system processes and regulatory requirements.
• Knowledge of regulations governing computerised systems and control.
• Experience in manufacturing/packaging of solid oral dosage forms (advantage).

Responsibilities

• Develop, implement, and support electronic Quality Systems across the Global Pharma Services network.
• Drive design, validation, and ongoing support of Quality Systems; act as SME for CSV and regulatory compliance.
• Lead documentation and lifecycle activities, contribute to audits, ensure systems meet business needs and industry standards.

Skills

Quality systems

CSV (Computer Systems Validation)

Regulatory compliance

Quality System architecture

Education

Degree in Life Science or related discipline

Job description

Global Quality Systems Senior Specialist

The successful candidate will play a pivotal role in developing, implementing, and supporting electronic Quality Systems across our Global Pharma Services operations.

This is an exciting opportunity for an experienced quality professional who is passionate about system excellence, regulatory compliance, and driving continuous improvement on a global scale.

As a Global Quality Systems Senior Specialist, you will be instrumental in driving the design, implementation, validation and ongoing support of Quality Systems throughout our global network. Working closely with international sites, internal IS teams and external partners, you will act as a subject matter expert (SME) in Quality System architecture, Computer Systems Validation (CSV), and regulatory compliance.

You will support key projects, lead documentation and lifecycle activities, contribute to audits, and ensure that systems meet both business needs and industry standards.

Key Requirements:

Degree (or equivalent) in a Life Science or related discipline.

Significant experience working within a regulated Quality System (GMP, ISO, etc.).

Strong understanding of pharmaceutical quality system processes and regulatory requirements.

Knowledge of regulations governing computerised systems and control.

(The following criteria may be applied if a large pool of applicants exist)

Experience in manufacturing/packaging of solid oral dosage forms.