Job Description
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:
1. Manage and update a comprehensive QMS that aligns with ISO 9001 and GXP regulations.
2. Conduct regular quality reviews of business processes to ensure they meet quality standards.
3. Ensure compliance with EMA and FDA GXP requirements, particularly for software development and validation to CFR21 part 11.
4. Foster a culture of quality throughout the organization.
5. Lead client and regulatory audits.
6. Manage and maintain the ISMS and ISO 27001:2022 certification.
7. Implement information security measures to protect sensitive data.
8. Liaise with external DPO to ensure compliance with data protection laws such as UK and EU GDPR.
9. 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.
10. Report sustainability progress and key metrics to clients....