Head of Quality & Operations

Proclinical is seeking a Head of Quality and Operations to play a pivotal role in ensuring the continued success of our quality management and operational activities. This position involves developing and maintaining a robust quality management system (QMS) aligned with ISO 9001 and GXP regulations, managing data protection obligations. The successful candidate will also handle day-to-day business operations including resourcing, planning, and performance monitoring.

Responsibilities:

• Manage and update a comprehensive QMS that aligns with ISO 9001 and GXP regulations.
• Conduct regular quality reviews of business processes to ensure they meet quality standards.
• Ensure compliance with EMA and FDA GXP requirements, particularly for software development and validation to CFR21 part 11.
• Foster a culture of quality throughout the organization.
• Lead client and regulatory audits.
• Manage and maintain the ISMS and ISO 27001:2022 certification.
• Implement information security measures to protect sensitive data.
• Liaise with external DPO to ensure compliance with data protection laws such as UK and EU GDPR.
• Maintain certified B-corp status, oversee annual GHG audit and reporting, track and monitor KPIs, produce annual public impact reports, and oversee progress towards Net Zero status.
• Report sustainability progress and key metrics to clients.
• Complete annual Ecovadis survey.
• Allocate resources effectively to support operational/project activities.
• Develop and implement operational plans for efficient service delivery.
• Monitor project performance and identify areas for improvement.
• Work with finance to deliver summary management reports on business performance.
• Drive continuous improvement initiatives across all operational areas.

Key Skills and Requirements:

• Bachelor's degree in a relevant field (e.g., quality management, engineering, science).
• Strong understanding of ISO 9001 standard and GXP regulations.
• Experience managing an ISMS and ISO 27001:2022 standard.
• Knowledge of data protection laws and regulations.
• Experience with QMS in software development processes and validation to CFR21 part 11.
• Familiarity with EMA and FDA GXP requirements.
• Experience in technology-enabled services for the pharmaceutical sector.
• Understanding of safety risk management.
• Strong leadership skills with the ability to motivate and inspire.
• Excellent communication and interpersonal skills.
• Experience in a consulting or professional services environment is preferred.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.