Position located in Boston, MA

Responsibilities of the Assistant Director/Director (GCP/GXP Audit):

• Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation).
• Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process.
• Identify need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).
• Write and review SOPs to assess consistency and compliance with regulatory requirements/internal standards and determine/ensure effective implementation across the organization.
• Provide guidance to Clinical Operations staff and other GCP-related departments, as applicable, based on interpretation of current regulations to ensure best practices including risk-based management.
• Provide guidance with the identification and management of risks in clinical trial activities and monitor/evaluate risk management activities.
• Work closely with Clinical Operations and other GCP-related departments, as applicable, to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues in a timely manner, including approval of corrective action/preventative action (CAPA) plans, as necessary.
• Participate in the review of drug safety practices for clinical trial compliance.
• Provide functional review of clinical protocols, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents.
• Assist and advise with training QA and clinical staff as necessary for GCP.
• Collaborate with applicable departmental heads to identify clinical trial and regulatory training needs of Clinical Operations (and other Clinical trial members) based on regulatory changes, process/system changes, audit findings, trends, etc., and assist in coordinating the training to meet the needs.
• 40% travel domestic and international required.

Qualifications of the Assistant Director/Director (GCP/GXP Audit):

• BS or MS with 8+ years GCP biotech/pharma experience.
• Must have experience with GCP, GXP, and ICH requirements, especially ICH E6R2 as well as Canadian and EU trial regulations.
• Excellent written and oral communications skills.
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders.
• Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment.