Senior Director, GCP Quality

Position Summary

The GCP Quality Assurance candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by company. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices.

Key Responsibilities

• Write and/or 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.
• Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation).
• Identify need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).
• 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.
• 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,, and assist in coordinating the training to meet the needs.
• Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management.
• Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.
• Provide guidance with the development and management of key vendor oversight activities for clinical trials and monitor/evaluate the oversight activities.
• Assist senior staff during regulatory inspections.
• Ability to travel domestic and international.
• Other duties, as required.

Qualifications

• BS in a life science required
• At least 10 years of direct GCP pharmaceutical/biotechnology experience
• Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6
• Excellent written and oral communications skills

Additional information

A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments

• Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
• The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Understanding of the drug and biologic development and clinical research processes
• General understanding of non-clinical research and manufacturing processes including terminology
• Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing

Salary Range

$230,000 - $281,000 USD

This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.