Manager II, Clinical Quality Assurance

the Tarsanet Internal Career Center•Irvine, CA

1d•$120,000 - $168,000•Hybrid

About The Position

Reporting to the Director of Clinical Quality Assurance, the Manager II, Clinical Quality Assurance, is responsible for clinical quality support and management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) supplier qualification program. The successful candidate will assist in inspection readiness activities across the company, training and ensuring adherence with current ICH GCP E6 guidance and applicable regulations.

Requirements

8 years of experience in clinical
5 years of experience within the pharmaceuticals industry
Bachelor’s Degree in Scientific Field Preferred
In-depth knowledge of clinical trial related FDA regulations, ICH Guidelines, and experience with international GCP/GLP/GVP regulations and guidelines is desired.
Extensive knowledge in Risk-Based Management (RBM), global clinical regulations and clinical development.
Experience with investigations using root cause analysis, corrective and preventive actions (CAPA) and CAPA effectiveness checks.
In-depth knowledge of auditing planning, principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies.
Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implementing them effectively to reduce errors.
Ability to adapt to shifting priorities in a fast‑paced environment.
Strong computer and organizational skills.
Strong attention to detail.
Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

Responsibilities

Provide day-to-day clinical quality support and training, as appropriate, to ensure adherence with applicable regulatory requirements, company policies and procedures.
Coordinate all GCP/GLP/GVP related internal and supplier audit activity including management and maintenance of the qualification program’s audit schedule within the Quality Management System (QMS).
Perform supplier audits and prepare author reports, as needed.
Compile audit responses and review implementation evidence.
Support the implementation of quality systems and processes within the Clinical Quality area.
Review and approve QMS records (deviations, corrective and preventive actions (CAPAs), change controls, etc.) for completeness and adherence to Standard Operating Procedure (SOPs) and applicable regulations.
Assist in remediation and corrective action plans and monitor quality issues to resolution.
Assist with the review of Clinical Quality Management Plans (CQMPs) for clinical trials and/or vendor performance, as needed.
Responsible for the management of clinical training curricula.
Assist in the creation of tracking tools to report quality metrics, as necessary.
Support the review of and/or perform Risk Assessments, as needed.
Assist with oversight and conduct periodic reviews of clinical trial systems (e.g. Clinical Trial Management System (CTMS), Trial Master File (TMF), etc.).
Work closely with Quality Management to ensure compliance with applicable guidelines, regulations, and SOPs.
May serve as a resource for Clinical Development/Operations and Quality.