GCP Quality Manager

Job Summary

Under the leadership of the Director of Development Operations Quality (DOQ) or designee, this position supports the Operations Quality Lead for DOQ collaborations with Quality Assurance. This position supports the development and implementation of initiatives and established processes that support operations in maintaining inspection readiness. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness. This position may sit across the entire global portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA), the Operations Quality Lead, and the Operations Quality Manager, as needed. With QA leading, this position supports study teams during regulatory inspections.

Summary of Job Responsibilities

1. Under the leadership of the Operations Quality Lead, supports or may lead inspection readiness initiatives.
2. Creates process and tools to achieve inspection readiness within Development Operations.
3. With DOQ leadership, helps to facilitate the growth of opportunities for collaboration with QA, collaborating with the Operations Quality Lead and the Operations Quality Manager.

Study Team Support Activities

1. Become thoroughly familiar with assigned compounds and protocols.
2. Support overall quality within assigned clinical trials and submissions.
3. For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed.
4. Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends.
5. Provide training and coaching to promote awareness educating study teams towards quality deliverables.
6. Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables.
7. Work with teams to escalate quality issues with CROs to QA, supporting teams to bring CROs into compliance; and look for opportunity to collaborate with other members of DOQ to trend across Strategic Partnership(s) to communicate to QA.
8. Work with Study Team leadership (and QA, as needed) to identify quality issues and plan of action, including support for creation of deviations and development of effective CAPA.
9. Support inspection readiness activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and DOQ Director or designee.
10. Plan and lead Study Team inspection readiness support meetings based on QA's plan and Study Team's needs.
11. Support QA in their inspection readiness team meetings and collaborate with QA for information needed and requested for any inspections.
12. Assist with stakeholder engagement across program to ensure compliance with inspection readiness and preparation activities.
13. Support teams in preparation, execution, and follow-up of regulatory inspections.
14. Review critical/major findings with QA Audit reports to propose process improvement.
15. Provide consult on KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality.

General Responsibilities

1. Develop and maintain guidance and process to facilitate DOQ support of Study Teams.
2. Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis.
3. Provide training or awareness for new or established processes or guidance provided by DOQ.
4. Collaborate in developing and presenting DOQ content for distribution within the organization.
5. Author relevant content for the DOQ SharePoint site.
6. Act as lead on specified DOQ workstreams or assigned DOQ initiatives.
7. In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests that are sent to DOQ.
8. Consult, develop, or identify opportunities for continuous improvement projects.
9. Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations.
10. Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials.
11. Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus.
12. Develop matrix relationships to involve process experts and conduct improvement activities.
13. Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization.
14. Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do.

Skills/Experience

1. Working knowledge of Quality Management methods, systems, and relevant procedures.
2. Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials.
3. Experience in managing complex and sensitive operational challenges.
4. Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements.
5. Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders.
6. Experience in developing or contributing to processes and/or SOPs and/or WIs.
7. Ability to lead and execute continuous improvement.
8. Experience in inspection preparation, participation, and follow-up.
9. Experience with audits and inspections of sponsor/CRO/site/vendor.
10. Exposure to all phases of clinical trials.
11. Broad knowledge of Clinical Operations with prior regulatory knowledge desired.
12. Demonstrated leadership, critical thinking skills, and ability to influence teams driving them to shared consensus.
13. Strong verbal and written communication skills with ability to effectively communicate with a broad range of stakeholders at all levels to build strong, positive relationships under challenging and evolving landscapes.
14. Ability to interact with key stakeholders and create and present complex information effectively to promote excellence in quality.
15. Acute attention to details with ability to extrapolate facts and communicate succinctly and confidentially.
16. Strong cooperative team player with the ability to be flexible and adapt to a changing environment.
17. Used to working in a multidisciplinary setting with a strong customer-orientation.
18. Ability to effectively manage multiple priorities simultaneously.
19. Good planning, prioritization, and organizational skills, and able to work independently or within a group.

Minimum Requirements

1. Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience.
2. Bachelor's degree or equivalent with a strong emphasis on science or quality management.
3. Minimum of 5 years' experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
4. Minimum of 3 years' experience in quality role.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com