DFnet provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DFnets people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global health. DFnet helps researchers manage and analyze data across 18 therapeutic areas with clinical sites in over 35 countries. Our work includes HIV, TB, Malaria, Ebola, and other tropical diseases. We are a fully remote organization with team members in South Africa, Canada, and the United States.

DFnet is seeking a Director of Quality, who leads the organization's quality assurance and compliance efforts, ensuring adherence to 21 CFR 11, ICH E6, Annex 11, and Good Clinical Practices. Oversees internal quality audits and supervises the Quality Department. As Chief Data Protection Officer, ensures compliance with HIPAA, GDPR, and other applicable privacy laws, acting independently to safeguard the privacy and rights of clinical trial subjects and others whose data is held by DFnet.
Essential Duties and Responsibilities:

Quality Strategy and Leadership:

• Develops and executes a comprehensive quality and compliance strategy aligned with organizational goals, national regulations, and industry best practices.

• Sets clear team goals; oversees day-to-day operation; monitors team performance and support

• Collaborates with Directors and staff responsible for software development, computerized systems, and data management practices to ensure DFnet meets regulations and follows recognized best practices.

Regulatory Compliance:

• Oversees and ensures compliance with ISO 9001, ISO 27001, ICH, and regulations in each jurisdiction where the company collects and processes data.

• Stays informed about changes in regulatory requirements in any jurisdiction where DFnet collects or processes data, proactively addresses compliance issues, and trains staff as needed.

• Develops and maintains the Quality System, including Policies, Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), and Plans.

• Maintains all records needed to provide evidence that each staff member has the training and experience required to accomplish their assigned duties following applicable regulations, commonly recognized best practices, and approved company policies and procedures.

• Monitors and ensures compliance with HIPAA, GDPR, and any other privacy regulations that involve DFnet staff, clients, study participants, or other individuals on whom DFnet stores or processes data.

Quality Management Systems:

• Designs, implements, and maintains robust quality management systems that support organizational objectives.

• Drives continuous improvement initiatives to enhance the effectiveness of quality processes.

• Oversees validation of computerized systems used to collect and manage clinical data.

Quality Audits and Assessments:

• Plans and conducts internal audits to assess compliance, identify areas for improvement, and follows up on issues identified.

• Host audits requested by clients and potential clients to demonstrate that the company meets applicable regulations and common expectations for quality and security.

• Drafts responses to audit findings.

• Conducts vendor audits to prevent supply chain vulnerabilities.

• Regularly reviews organizational controls and ensures corrective actions are taken when necessary to ensure logical security.

• Collaborates with regulatory authorities and external partners as needed.

• Addresses nonconformities identified in previous internal and external audits.

• Ensures that documentation and design controls align with organizational standards.

Risk Management:

• Develops and maintains a robust risk management framework to identify, assess, and mitigate quality-related risks.

• Oversees integration of data protection principles into systems, projects, and processes from design to retirement.

• Leads data protection compliance efforts, including employee training, breach response procedures, and facilitation of data subject rights (e.g., access requests, portability, right to be forgotten).

• Reviews Data Processing Agreements and monitors third-party vendors to ensure compliance with GDPR, HIPAA, and company policies.

• Serves as the primary liaison with data protection authorities, clients, potential clients, and internal teams on privacy-related matters.

Continuous Improvement Initiatives:

• Drives initiatives for continuous improvement in quality processes, systems, and overall organizational performance.

• Measures and monitors the effectiveness of quality programs.

Cross-Functional Collaboration:

• Collaborates with cross-functional teams to integrate quality considerations into all aspects of the business, from product development to post-market activities.

• Works closely with other departments to ensure a holistic approach to quality across the organization.

Team Development and Mentoring:

• Leads and supervises the Quality team, establishing clear goals, overseeing daily operations, and optimizing resource utilization.

• Supports team development through coaching, training coordination, performance monitoring, and recognition of achievements.

• Fosters a positive team environment through open communication, active listening, and prompt conflict resolution.

• Manages departmental HR tasks, including hiring, performance reviews, timesheets, and expense approval, in collaboration with HR.

Must-haves:

• Bachelorsdegree in ascience-related field.

• 5+ years of comprehensive experience in all facets of Clinical Data Management, encompassing data entry and review.

• 5+ years ofexperience conducting computerized systems validation.

• 5+ years ofexperience conducting audits and responding to auditfindings.

• Proven experience in data protection, privacy, or compliance roles, with a deep understanding of GDPR.

• Strong knowledge of data protection laws and regulations.

Nice-to-haves:

• Masters degree in a Science-related field preferred.

• 10 years of experience in a leadership role in quality management.

• Understanding of Food and Drug Administration (FDA) and National Institutes of Health (NIH) regulations

• Legal or compliance background.

We are looking for:

• Demonstrated ability to adhere to industry regulatory requirements, standards, and DFnet Research Standard Operating Procedures (SOPs).
• Availability during scheduled work hours and responsiveness to emails, messages, and calls; availability occasionally work outside standard office hours as needed.
• Strong interpersonal and communication skills characterized by professionalism and a commitment to maintaining confidentiality.
• Proficiency in using MS Office and remote work tools.
• Superior organizational abilities and the ability to adapt to a constantly changing environment.
• Excellent time management skills with the ability to effectively prioritize tasks.
• Exceptional written and verbal communication skills.
• Strong problem-solving and decision-making abilities.
• Meticulous attention to detail in all tasks.
• Ability to work collaboratively in a team environment.

Working conditions:

• Theemployees areexpected to provide their own workspace equipped with necessary tools(equipment is provided by the company)and a secure internet connection.
• Adherence to all security protocols, including password protection, data encryption, and regular software updates.
• Work may require extended periods of sitting and repetitive use of a computer for tasks.

This job description does not encompass all the duties and responsibilities associated with this position. The nature of these duties may evolve at any time, with or without prior notification.