Summary of Position
The Manager Clinical QA and Auditing will be responsible for: (i) auditing sponsor processes, trial master files, investigator sites, vendors (e.g., CROs) and systems under the guidance of a senior member of the department, and (ii) ensuring quality activities are performed and documented in compliance with corporate policies and standards, and all applicable global regulations with minimal supervisory oversight.
Roles of Responsibilities
The Manager Clinical Quality Assurance and Auditing will be responsible for:
- Conducting Good Clinical Practices (GCP) Risk Assessments.
- Assisting in the development and implementation of the annual QA-GCP audit plan using a risk-based approach.
- Developing an audit agenda and communications (e.g., pre-audit document requests) with auditees for each assigned audit project.
- Conducting audits and meeting the following requirements:Ensure timelines for completion of audits are met.
- Comply with all applicable SOPs, policies, global regulations, etc.
- Escalate audit issues/concerns to QA management.
- Produce audit reports and corrective action tables.
- Develop status reports which key metrics on audit progress.
- Issues applicable audit certificates.
- Management of corrective and preventive action tables.
- Maintain accurate and timely documentation of assigned QA activities.
- Preparing with line functions and QA management in the development of corrective action plans.
- Analyzing and reporting trends in audit findings, as requested.
- Reviewing and assessing key metrics (i.e., quality of TMF structure, risks, time for project, etc.).
- Developing training material/activities for auditees.
- Participating in program and protocol team meetings as the QA Representative.
- Maintaining knowledge on industry leading practices and current regulations surrounding GCP compliance.
- Participating in regulatory inspection activities for sponsor and sites.
- Reports to Director, Clinical Quality Assurance.
Qualifications and Background Requirements
- BA/BS degree within a scientific discipline.
Professional Work Experience
- A minimum of 5-8 years in the Pharmaceutical/Biotechnology industry is required with at least 2 to 4 years of independent GCP auditing experience preferably in relation to sponsor, site, central lab and vendor audits required
- Pre-Approval Inspection readiness audit experience required.
- Experience in clinical operations and handling trial essential documents is required.
- Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP guidelines.
- Working independently to complete assigned tasks.
- Solid written and verbal communication skills, analytical and problem solving skills.
- Flexible, highly motivated, with strong organization skills and the ability to multitask.
- Be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
- GLP auditing experience is a plus.
- Knowledge of GXPs is a plus.
- Proficient Computer Skills: Specifically MS Word, MS Excel, MS PowerPoint, MS Project proficiency is a plus.