Current opportunities

Title - Quality Assurance Auditor (GCP)

Summary

This position is responsible for the planning, delivery and execution of the Good Clinical Practice (GCP) QA program on assigned projects/products and global GCP audit activities. The role is responsible for GCP oversight, and for assuring the compliance of clinical trial projects to ARIAD Standard Operating Procedures (SOPs) & Policies, and applicable worldwide regulations and guidelines (e.g. US FDA, EMEA, ICH, and country-specific regulations). Significant opportunity for growth. Salary dependent upon experience.

This position will report to the Assoc Director, GCP Audits & Compliance and will require 25-30% travel for conducting audits, including international travel. Candidate must possess excellent oral & written communication and interpersonal skills, as well as computer proficiency, with a demonstrated ability to work independently.

Training & Education Preferred:

• Bachelor’s degree is required.
• Equivalent relevant professional experience may be considered.
• A  medical related degrees is a strong plus

Preferred Prior Experience

• Two to three (2-3) years experience in drug development, clinical research, regulatory compliance, and clinical study monitoring or equivalent.
• Minimum of (1-2) years previous clinical Quality Assurance (GCP) experience, independently conducting a broad range of audits including investigator sites, vendors, processes, databases and regulatory submission documents.
• Experience in oversight of clinical studies as a GCP Quality representative.
• Some experience in training others on GCP compliance issues.

Competencies

• Knowledge of the drug development process, GCP/ICH guidelines is essential.
• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a balanced business perspective
• Understanding of or experience in Pharmacovigilance is a plus.
• Ability to collaborate effectively across departments and organizations.

Duties

• Assist in developing SOPs for the management and oversight of GCP activities.
• Develop written QA plans for assigned projects/products.
• Assess compliance of clinical investigator sites, vendors, and ARIAD programs to FDA, ICH, and other government agency regulations/ guidelines.
• Conduct GCP audits of clinical studies at Clinical Investigator sites
• Conduct audits of regulatory documents, sponsor processes/procedures, clinical trial databases and vendor/services providers (CROs, Clinical Labs etc.).
• Report results to project team personnel and management, and interact with various teams to ensure corrective actions are taken and to bring audit observations to closure.
• Participate in special assignments on various projects (including inspection readiness) as determined by QA management.