The Quality Assurance GCP Manager is responsible for arranging, conducting and reporting on GCP audits of clinical research organizations, vendors, and systems as well as oversight of the Clinical Operations and miRagen Clinical Trials. Participates in cross-functional teams providing guidance and risk-based options. Reviews study documents and checks for consistency and appropriate standards and practices. Assists in the creation and maintenance of audit tools. When appropriate, prepares and/or revises GCP SOPs and Work Instructions. Works with cross-functional teams to provide GCP advice. Maintains good working relationships and communication with GCP customers and staff. Essential duties include:
• Performs Quality Control (QC) of clinical and non-clinical data as well as clinical documents
(protocol, IB, etc.).
• Ensures Clinical Operations and miRagen Clinical Trials are complaint with FDA and ROW regulatory expectations;
• Arranges, conducts and reports on GCP audits of clinical research organizations, investigators, vendors, and systems
• Develops and maintain quality procedures aligned with GCP concepts
• Works within cross-functional teams, ensuring compliance to regulatory guidance and internal document standards;
• Works directly with CRO’s and other external contractors and collaborators, managing the chain of communication related to GCP compliance;
• Approximately 5-10% travel per year
Suitable candidates will possess a Bachelor’s degree in a Life Science or Engineering, and 8+ years of Quality Assurance experience in the Biotechnology and/or Pharmaceutical industry. Extensive knowledge of clinical trials in the US and EU and regulatory standards at all phases of drug development is preferred.
• Clear record of success as a QA Manager in a biopharma or pharmaceutical environment;
• Clear understanding of FDA and international regulatory requirements;
• Adept at prioritizing and completing tasks in a high-pressure environment;
• Proven leadership within a cross-functional project team;
• Ability to persuasively and effectively interact with partners, collaborators and CRO’s;
• Demonstrated ability to anticipate and address issues;
• Exceptional oral and written communication skills including excellent technical writing abilities.