Senior Director, GCP Quality

Remix Therapeutics•Watertown, MA

1d•$230,000 - $281,000

About The Position

Remix Therapeutics is a clinical-stage biopharmaceutical company developing medicines that modulate RNA splicing. Its lead program, REM-422, targets pre-mRNA splicing in oncology. The company is headquartered in Watertown, Massachusetts. 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 is responsible for ensuring the quality and compliance of those trials with company Standard Operating Procedures, applicable regulatory requirements—including US FDA, ICH, and country-specific requirements—and current industry standards and practices. The position works closely with Clinical Operations and other relevant departments, supports audits and regulatory inspections, and provides guidance on risk management, training, vendor oversight, and remediation of compliance issues. Domestic and international travel is required.

Requirements

Bachelor of Science degree in a life science.
At least 10 years of direct GCP experience in the pharmaceutical or biotechnology industry.
Solid understanding and application of GCP, GLP, and ICH requirements, especially ICH E6.
Excellent written and oral communication skills.
Well-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 knowledge to support 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.

Nice To Haves

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

Responsibilities

Write and/or review SOPs to assess consistency with regulatory requirements and internal standards and ensure effective implementation across the organization.
Advise Clinical Operations and other GCP-related departments on current regulations and best practices, including risk-based management.
Guide the identification and management of risks in clinical trial activities and monitor and evaluate risk-management activities.
Coordinate resolution of findings and non-compliant issues with Clinical Operations and other relevant departments, including reviewing and approving CAPA plans as necessary.
Participate in reviewing drug safety practices for clinical trial compliance.
Conduct and/or assist with internal audits of systems, processes, vendors, and computer system validation.
Identify the need for and conduct and/or assist with external audits, including investigator sites, central IRBs, CROs, and clinical laboratories.
Oversee responses to investigator site and CRO audits and inspections, and ensure that actions addressing findings are acceptable through the CAPA process.
Provide functional review of clinical protocols, informed consent forms, clinical study reports, and other clinical trial-related 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 arising from regulatory, process, or system changes, audit findings, and trends, and help coordinate training.
Identify potential systemic gaps and coordinate timely remediation with appropriate stakeholders; escalate critical non-compliance or insufficient urgency in remediation to senior management as appropriate.
Conduct program-specific root cause analysis 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.