Head of Quality at Indeed

london, London - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

16 Dec, 26

Salary

90000.0

Posted On

17 Sep, 26

Experience

15 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical & Personal Care Products

Description

Full job description

Our client is a leading provider of clinical research and diagnostic solutions for the life sciences sector. The Cambridge facility supports production, research and development, distribution, customer training, and product demonstrations.

They are seeking a Head of Quality to lead the Quality function across the site (reporting to the group Director and SMT).

The Head of Quality will maintain an effective, inspection-ready Quality Management System that supports regulatory compliance, product quality, continuous improvement, and cross-functional operational excellence.

Responsibilities

Lead, develop, and mentor the Quality team, setting clear objectives, accountabilities, and performance expectations
Ensure the Quality Management System is established, implemented, maintained, and improved in line with applicable regulatory and GxP requirements
Provide Quality Operations oversight across the site, ensuring compliant processes, documentation, equipment, environment, people, systems and product release decisions
The Head of Quality will promote continuous improvement through quality metrics, KPIs, trend analysis, risk management, CAPA, deviation management, change control, and audit findings
Maintain inspection and audit readiness, supporting regulatory inspections and external audits by coordinating responses and presenting QMS information
Partner with Operations, Regulatory Affairs, R&D, Medical Affairs, Commercial, IT, Manufacturing, Supply Chain and other functions to embed compliant and sustainable quality practices
Influence stakeholders to adopt quality system improvements, including eQMS enhancement programmes and future electronic batch record developments

Essential requirements

The Head of Quality will have either quality, regulatory, technical, production, scientific or related experience in a pharmaceutical, biotechnology, IVD, clinical research, medical device, or similar environment
Working knowledge of quality management systems, GxP expectations, GMP, Good Documentation Practice, ALCOA principles, electronic systems, and inspection/audit readiness
Experience using quality metrics, KPIs, risk-based approaches, and continuous improvement tools to assess QMS performance and drive effective action
Experience with an electronic Quality Management System
Ability to lead, collaborate cross-functionally and influence stakeholders

Desirable experience (not deal breakers)

Knowledge of IVD, CDx, IVDR, FDA 21 CFR, process validation, equipment validation, and computer systems validation (CSV)
Technical or scientific knowledge relating to the manufacture, commercialisation and distribution of regulated diagnostic or medical device products

Pay: £70,000.00-£80,000.00 per year

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Responsibilities

Full job description

They are seeking a Head of Quality to lead the Quality function across the site (reporting to the group Director and SMT).

Responsibilities

Lead, develop, and mentor the Quality team, setting clear objectives, accountabilities, and performance expectations
Ensure the Quality Management System is established, implemented, maintained, and improved in line with applicable regulatory and GxP requirements
Provide Quality Operations oversight across the site, ensuring compliant processes, documentation, equipment, environment, people, systems and product release decisions
The Head of Quality will promote continuous improvement through quality metrics, KPIs, trend analysis, risk management, CAPA, deviation management, change control, and audit findings
Maintain inspection and audit readiness, supporting regulatory inspections and external audits by coordinating responses and presenting QMS information
Partner with Operations, Regulatory Affairs, R&D, Medical Affairs, Commercial, IT, Manufacturing, Supply Chain and other functions to embed compliant and sustainable quality practices
Influence stakeholders to adopt quality system improvements, including eQMS enhancement programmes and future electronic batch record developments

Essential requirements

The Head of Quality will have either quality, regulatory, technical, production, scientific or related experience in a pharmaceutical, biotechnology, IVD, clinical research, medical device, or similar environment
Working knowledge of quality management systems, GxP expectations, GMP, Good Documentation Practice, ALCOA principles, electronic systems, and inspection/audit readiness
Experience using quality metrics, KPIs, risk-based approaches, and continuous improvement tools to assess QMS performance and drive effective action
Experience with an electronic Quality Management System
Ability to lead, collaborate cross-functionally and influence stakeholders

Desirable experience (not deal breakers)

Knowledge of IVD, CDx, IVDR, FDA 21 CFR, process validation, equipment validation, and computer systems validation (CSV)
Technical or scientific knowledge relating to the manufacture, commercialisation and distribution of regulated diagnostic or medical device products