The Clinical Trials / GCP QA 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 E6, etc). This role will also be responsible for the development, maintenance and oversight of the GCP activities related to clinical trials sponsored by the company. This role will work in collaboration with the Quality, Program Leads, Director of Operations, Project Leads and Teams to develop, operationalize, and communicate policies, processes and procedures. The GCP QA 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. Key aspects and responsibilities of the role include:
1. Holding primary responsibility for the development of the 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. Reviews and updates SOPs, identifying the need for new SOPs, including the development of training materials and conducting training.
2. Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable.
3. Acts as primary administrator of the electronic Quality Management System, including document control and employee training.
4. Monitors and tracks ongoing SOP compliance and deviations and develops Corrective and Preventive Actions (CAPAs).
5. Participates in the evaluation and qualification of CROs and other vendors in compliance with the company's SOPs.
6. Lead qualification, routine and for-cause audits suppliers including Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors.
7. Conducts internal audits (systems, processes, vendors, computer system validation). Develops and implements Clinical QA plans to meet GCP quality standards, policies, and procedures.
8. Responsible for execution of an Inspection and Audit Readiness program and evaluate audit observation trends and escalate as required to applicable functional leads.
9. Conduct Clinical Study Report (CSR) and Trial Master File (TMF) audits.
10. Conducts reviews of clinical, regulatory, and other applicable documents, ensuring quality, accuracy, and completeness.
11. Supports the Clinical Operations team with the preparation, coordination, and management of regulatory agency inspections.
12. Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization.
13. Leads and supports periodic review of documents, revising them as appropriate in collaboration with relevant Project Teams.
14. Ensures real time Sponsor inspection readiness, and supports CRO with clinical site inspection readiness.
15. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
In addition, the GCP QA Manager will be responsible for:
1. Performing SOP gap analyses for vendors as appropriate, including CROs.
2. CRO clinical operations team qualification/verification.
3. Collation and write up of historical activities.
4. Provides expertise and guidance in consistent, risk-based interpretations of governmental regulations, agency guidelines and internal policies to assure GCP compliance.
5. Works 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.
Take the next step in your career and Apply Now!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.