In partnership with the Quality Assurance Lead (QAL), the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. The QAS will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
The QAS position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations). Primary activities include, but are not limited to:
- Prepares, conducts Quality Assurance (QA) audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g., Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
- Activities may include GCP and PV routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations and due diligence activities.
- Will represent QA as single point of contact and provides QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries.
- Serves as member of project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.
- Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
- Contributes to the QA strategy and support s QA goals for the aligned studies/countries in a given TA/Region.
- Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
- In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
- In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).
- Be able to analyze and leverage quality indicators and data to identify potential trends and risks and perform root cause analyses to enable principles of knowledge-based auditing within respective TA and/or region.
- Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions. Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.
- Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
- Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Provide inspection management support as appropriate.
- Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
- Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and
- guidelines as well as local regulations.
- Promotes standardization of auditing approach within QA.
- Routinely suggests new audit techniques/aids in areas of technical expertise.
- Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
- Provides training and mentorship to less experienced members of QA staff.
- Ensures the work climate/culture within QA, exemplifies our Company's Leadership behaviors.
Education Minimum Requirements:
- BS/BA degree in relevant area with 8+ years of experience in the pharmaceutical industry.
Preferred Experience and Skills:
- GCP QA site audit experience.