Position Summary:

Support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

This position is responsible for the execution of the global Quality Assurance audit activities on assigned studies, clinical sites and vendors. This role is accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) Quality oversight, and for assuring the compliance of studies with our Company’s Standard Operating Procedures, policies, and all applicable worldwide regulations and guidelines.

Major Duties and Responsibilities:

  • Will represent QA as a single point of contact and provides QA guidance for studies.
  • Serves as a member of the 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 Quality and QA expertise.
  • 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 promote the implementation of associated risk mitigation strategies.
  • In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
  • Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements)
  • 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.
  • 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 to the Heads of Quality and Clinical Operations.
  • 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 processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company’s policies, procedures and industry standards.
  • Lead the GCP sponsor inspection readiness program for pivotal/registrational clinical trials.
  • During inspections or internal audits, manage functional teams by assigning requests to appropriate functional SMEs; providing necessary follow-up and guidance to ensure timely fulfillment; liaising with functional SMEs and QA to assure alignment; providing regular status updates to appropriate stakeholders and leadership.
  • Prepares and 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 Good Clinical Practice (GCP) and Pharmacovigilance (PV) routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations, and due diligence activities.

Position Requirements:

  • At least 7 years of Clinical Quality experience
  • Broad and in-depth knowledge of the drug development process, Good Clinical Practice guidelines, and applicable regulations is essential.
  • Experience as a clinical quality professional is required.
  • Experience as a clinical quality auditor is required.
  • Experience as inspection readiness lead is required.
  • Logic and analytical skills using rigorous logic and methods to solve difficult problems with effective solutions.
  • Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.

Education:

Bachelor’s degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.