Quality and Compliance Manager

uMed; United Kingdom; On-site; GBP 60,000 - 80,000

Job description

What is uMed?

The process of conducting clinical research is incredibly expensive and time-consuming, limiting our efforts to find answers to the world's most important medical challenges. uMed is a clinical research network fit for the 21st century, underpinned by cutting edge technology that connects patients, electronic health data and research groups across the world. Our rapidly growing network covers over 350 GP sites in the UK representing over 3,500,000 patients as well as a network of US healthcare providers representing a further 3 million patients. uMed was founded by an NHS doctor and is backed by UK and US venture capital.

The role:

uMed is looking for an experienced Quality and Compliance Manager to join our fast growing team. The Quality and Compliance Manager will maintain our quality manual and quality system, oversee ISO compliance, coordinate and/or perform external and internal audits. The role also involves ensuring compliance with healthcare data regulations (e.g., HIPAA, GDPR, MDR). You should have at least 5 years of experience managing quality and compliance in a healthcare or life science organisation. You will play a key role with overall responsibility for all aspects of quality and compliance in a cutting edge health technology company that is creating a huge impact for patients and society by accelerating medical research.

Key Responsibilities:

1. Develop and Manage Quality Documentation: Lead the creation, review, and maintenance of Standard Operating Procedures (SOPs) and other Quality Management documents, ensuring alignment with company policies and regulatory requirements.
2. Oversee Training Programs: Design and manage training initiatives to ensure company-wide understanding and adherence to quality and compliance standards.
3. Maintain Quality Systems: Manage the quality manual and overall quality management system, ensuring robust and effective processes are in place.
4. Ensure Certification Compliance: Take ownership of compliance with key certifications, including (but not limited to) ISO 27001, Cyber Essentials Plus, and the DSP Toolkit.
5. Collaborate Across Teams: Work closely with cross-functional teams and leadership to identify and address quality and compliance gaps or risks.
6. Monitor Regulatory Changes: Stay up-to-date with evolving standards, legislation, and industry best practices, implementing changes as needed.
7. Lead External Audits: Act as the primary contact for external audits conducted by sponsors, healthcare organizations, and regulatory agencies.
8. Manage Compliance Tools: Select and maintain tools and systems needed to support quality and compliance functions.
9. Report and Mitigate Risks: Analyze compliance risks and incidents, providing timely reports and recommendations to senior management.
10. Handle Incident Reporting: Coordinate responses to data breaches and oversee incident reporting protocols.
11. Conduct Compliance Audits: Perform regular internal audits and assessments to proactively identify and mitigate risks.
12. Develop Training Programs: Design and implement staff training on data protection, quality standards, and compliance practices.
13. Enhance Data Governance: Establish and maintain data governance frameworks, policies, and procedures.
14. DPO: As uMed's DPO, you will be responsible for ensuring the company's compliance with data protection laws and regulations, overseeing data privacy policies, risk assessments, and data security practices.

Requirements:

1. Minimum 5 years of experience in quality and compliance, preferably in a MedTech, healthcare, or similarly regulated industry.
2. Proven expertise with healthcare quality and compliance frameworks.
3. Strong ability to prioritize and manage a busy workload in a fast-paced environment.
4. In-depth understanding of the regulatory and governance challenges faced by health tech SMEs.
5. Familiarity with key standards and regulations, including ISO 27001, HIPAA, GDPR, Cyber Essentials Plus, and the DSP Toolkit.
6. Practical experience managing and maintaining ISO-compliant products with effective operational governance processes.
7. Excellent problem-solving, analytical, and communication skills.
8. Collaborative mindset with the ability to influence and engage cross-functional teams.