Quality Support Specialist Jobs

Summary

This is a remote full-time employee position. The role is fully integrated within a major pharmaceutical company.

The Quality Support Specialist will be the lead on (1) the development and implementation of the quality control (QC) integration management, and (2) managing the sponsor internal quality incident management in partnership with clinical data science (CDS) stakeholders and sponsor R&D quality and medical governance (R&D Q&MG). The Quality Support Specialist will employ a proactive approach in developing and implementing QC processes to continuously assess the quality of CDS operations, identifying process and/or procedural improvement opportunities, and building overall quality measurement within CDS.

Qualifications

• Excellent customer service and project management skills
• Ability to analyze trends and determine strategic improvement needs
• Strong quality foundation to manage the deviation and CAPA development
• Strong knowledge of ICH guidelines and understanding of current regulatory requirements (FDA, EMA, MHRA, etc.) related/applicable to the conduct of clinical trials
• Excellent oral and written communication skills; effectively communicate with all levels of the organization with good presentation and training skills
• Ability to bring consensus among diverse cross-functional teams and to drive results within established timelines
• Strong facilitation skills: ability to lead effective cross-functional meetings through discussions on complex and/or sensitive topics
• A minimum of 7 years’ experience working in clinical compliance, quality management systems, or clinical functional area with expertise and/or transferable skills with good clinical practice (GCP) and regulatory inspections
• Ability to take the initiative, prioritize assignments to meet deadlines, and produce results
• Ability to multitask handling a wide range of small, medium, and long-term assignments in parallel and dealing with urgent issues as they arise
• Ability to execute and monitor the implementation and process of such quality improvement processes
• Self-motivated with the ability to work and collaborate effectively in a dynamic environment

Responsibilities

QC Integration Management

• Collaborate in the development and implementation of integrated QC management within CDS
• Workwith CDS therapeutic area heads and/or delegate to identify and prioritize known issues and a list of potential critical processes/high priority studies to QC
• Revaluate responses to QC findings, verify evidence documents, and follow up as needed to ensure timely and accurate resolution
• Manage and coordinate QC activities including schedule, QC plan, conduct QC, written QC findings, and post-QC follow-up activities to ensure that non-compliance issues are addressed with satisfactory resolution
• Review QC findings with identified CDS subject matter experts (SMEs) and clearly communicate QC results and compliance risk to therapeutic area heads and/or delegate
• Centrally track and maintain QC required documents in a thorough and accurate manner
• Collect data on QC findings, prepare comprehensive QC metric reports, and analyze trends to identify process gaps and direct quality improvement and training initiatives
• Document detailed QC findings and recommendations in a timely manner that allows for proper review and assessment of identified issues and/or risks
• Identify areas for continuous improvement by providing feedback on CDS processes
• Present data trends and risk assessment to the applicable CDS therapeutic area heads and/or delegate

Internal Quality Incident Management

Manage and oversee the internal quality incident management for CDS through monitoring of complaints, deviations, and CAPAs. Activities include but are not limited to:

• Serve as record owner to enter and complete the internal deviations/CAPAs within Veeva Vault QMS in partnership with CDS deviation owner and sponsor R&D Q&MG
• Efficiently follow up and verify objective evidence documents to ensure that corrective and/or preventative actions are implemented as planned
• Facilitate a thorough and credible root cause analysis and CAPA discussion, including the development of a corrective action or preventative action for sentinel events
• Centrally monitor and manage the status of internal deviations/CAPA tasks relevant to CDS
• Liaise with global deviation management team
• Provide a deviation/CAPA training in relation to R&D regulatory compliance policies and procedures
• Coordinate and participate directly in the investigation of deviations/noncompliance/CAPA planning
• Manage non-compliance including deviation determination in consultation with sponsor R&D Q&MG, and CDS stakeholders
• Advise and consult on impact assessment and remediation plans
• Review deviation/CAPA reports to ensure documentation of deficiencies for comprehensive and remediation actions are appropriate prior to deviation/CAPA submission

Expectations

Looks for opportunities to expand breadth and depth of quality control, corrective actions, and/or clinical research experience. Assists the cross-functional team when possible. Provides outstanding customer service. Maintains a positive outlook and a growth mindset in all work activities.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Corporate Location

Foster City, CA. This role is US remote-based (home office) with travel as required.

Application

Only applications including a cover letter will be considered (the cover letter must be a page of your CV in order to be uploaded in LinkedIn). Please describe your relevant experience (minimum of 7 years required) and your specific skills that qualify you for this position. Please do not message or contact Trialwise directly.