The Clinical Quality Program Manager is responsible for developing and maintaining a compliance program including strategies and activities in accordance with relevant regulatory and legal guidelines and requirements (CFR 21, GCP, ICH, etc). This role will work in collaboration with the Senior Director, Quality Assurance, Senior Director of Clinical Development and Program Leads, and other teams to develop, operationalize, and communicate policies, processes and procedures. The Clinical Quality Program Manager must be detail-oriented and have the ability to identify and mitigate potential risks to the Clinical Research Team and wider organization as appropriate.
We are a small team of Quality professionals working to establish the Usona Institute Quality Management System, including all aspects of GCP. Working closely with the Usona CMC team and Clinical Operations, our team provides the Quality System direction for new product development from pre-phase 1 through market launch.
As part of this team, an understanding of current scientific and clinical research and a curiosity to learn will be used to guide development opportunities. The Clinical Quality Manager is a team player that brings a passion for clinical science, GCP compliance expertise and an eagerness to help develop and implement GCP processes at Usona.
You have previous clinical trial experience with expertise in compliance to national and international clinical trial regulations. You do not need to be an expert in all areas, but a strong Clinical Quality background and a willingness to learn and to a desire implement standard GCP processes are necessary. You are comfortable with clearly communicating your ideas and outcomes to colleagues and collaborators and enjoy working in a fast paced, team environment.
1. Holds primary responsibility for the development of the Usona GCP portion of the quality management system (QMS), including clinical and regulatory Standard Operating Procedure (SOP) and Work Instruction (WI) creation and continuous improvement. Ensures that comprehensive and consistent policies/procedures are established and maintained.
2. Acts as primary administrator of Usona’s electronic quality management system, including document control and employee training.
3. Leads and supports periodic review of documents, revising them as appropriate in collaboration with relevant Project Teams.
4. Ensures that forms and template documents are consistent with relevant SOPs and WIs.
5. Works with Clinical Operations to develop and implement risk mitigation plans for program projects and activities.
6. Monitors and tracks ongoing Usona SOP compliance and deviations, and develops Corrective and Preventive Actions (CAPAs).
7. Manages employee training and ensures training logs, job descriptions, org charts, and CVs are up-to-date (including GCP and HIPAA training for clinical trials personnel).
8. Acts as a point of contact for audits within the Clinical Research Team and wider organization.
9. Oversees eTMF compliance (in collaboration with CRO) through periodic reviews.
10. Ensures real time Sponsor inspection readiness, and supports CRO with clinical site inspection readiness.
11. Acts as GCP subject matter expert to provide internal guidance on regulatory and legal requirements.
12. Provide oversight of the quality and compliance activities required for the Clinical Development/Clinical Operations organizations.
13. Manage quality and compliance related work and priorities across the clinical teams, as well as Compliance and Audit partners, with employees and teams who are not direct reports.
14. Lead external inspection readiness, prep and support activities. Represent Clinical Quality strategy and execution and the Study Management Process/QMS during regulatory inspections.
15. Coordinate internal audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of medical devices approval and application.
16. Provide support on issues related to GCP compliance, training, interpretation and day to day operations.
1. Performs SOP gap analyses for vendors as appropriate, including CROs.
2. CRO clinical operations team qualification/verification.
3. Provide expertise and guidance in consistent, risk-based interpretations of governmental regulations, agency guidelines and internal policies to assure GCP compliance.
4. Work with Clinical leadership team and personnel on issues that require resolution and/or escalation.
1. Bachelor’s degree, preferably in the life sciences.
2. At least 7 years of clinical compliance, operations and/or quality, preferably in a clinical research setting.
3. Detailed knowledge of relevant regulations, standards, and best practices (CFR 21, GCP, ICH E6 etc.).
4. Ability to think critically and independently and to exercise sound judgment toward the resolution of issues.
5. Independent, self-starter with proven results in problem identification, planning, communication and project management.
1. Proficiency with Microsoft Word, Excel, and Outlook.
2. Experience developing or managing quality systems with a strong emphasis on GCP.
1. Ability to use computer equipment.
Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.