Senior Director, GCP Quality

Remix Therapeutics•Watertown, MA

About The Position

Remix Therapeutics is a clinical-stage biopharmaceutical company developing medicines that modulate RNA splicing. The Senior Director, GCP Quality will manage the development, maintenance, and oversight of Good Clinical Practice (GCP) activities related to company-sponsored clinical trials. The role ensures that trials meet company standard operating procedures, applicable regulatory requirements—including US FDA, ICH, and country-specific requirements—and current industry standards and practices. The position provides GCP guidance across Clinical Operations and other relevant departments, oversees risk management and audit activities, supports remediation and training, and reports compliance metrics and systemic issues to functional and senior management. Domestic and international travel is required. The role may also perform other duties as required.

Requirements

Bachelor of Science degree in a life science.
At least 10 years of direct GCP pharmaceutical or biotechnology experience.
Solid understanding and application of GCP, GLP, and ICH requirements, especially ICH E6.
Excellent written and oral communication skills.
Organized, self-motivated, and independent work style, with the ability to initiate and follow through on assignments.
Excellent interpersonal skills, including basic negotiation, influencing, and conflict-management skills for effective interactions within and across departments.
Ability to manage multiple project issues simultaneously while handling time demands, incomplete information, or unexpected events.
Understanding of drug and biologic development and clinical research processes.
General understanding of non-clinical research and manufacturing processes, including terminology.
Ability to travel domestically and internationally.

Nice To Haves

Broad experience in product development, clinical operations, regulatory compliance, and GCP auditing.

Responsibilities

Write and/or review SOPs for consistency with regulatory requirements and internal standards, and support their effective implementation across the organization.
Guide Clinical Operations and other GCP-related departments in interpreting current regulations and applying best practices, including risk-based management.
Guide the identification and management of clinical-trial risks and monitor and evaluate risk-management activities.
Coordinate resolution of findings and non-compliant issues with relevant departments, including review and approval of CAPA plans as necessary.
Participate in reviewing drug-safety practices for clinical-trial compliance.
Conduct or assist with internal audits of systems, processes, vendors, and computer system validation.
Identify the need for, conduct, or assist with external audits, including audits of investigator sites, central IRBs, CROs, and clinical labs.
Oversee responses to investigator-site and CRO audits or inspections, and assess whether actions to address findings through CAPA are acceptable.
Functionally review clinical protocols, informed consent forms, clinical study reports, and other clinical-trial documents.
Assist with and advise on GCP training for QA and clinical staff.
Work with departmental heads to identify clinical-trial and regulatory training needs based on regulatory or process changes, audit findings, and trends, and help coordinate training.
Identify potential systemic gaps and coordinate timely remediation with appropriate stakeholders.
Escalate critical non-compliance issues or insufficient urgency in remediation to senior management, as appropriate.
Perform program-specific root cause analyses of compliance issues and provide metrics for tracking and trending in QA reporting to functional and senior management.
Guide the development and management of key clinical-trial vendor oversight activities and monitor and evaluate those activities.
Assist senior staff during regulatory inspections.
Travel domestically and internationally.
Perform other duties as required.