Senior Director, GCP Quality

The role

The GCP Quality Assurance candidate will manage the development, maintenance, and oversight of GCP activities for company sponsored clinical trials. This role ensures quality and compliance with SOPs, regulatory requirements, and industry standards.

What you will do

• Write and review SOPs for regulatory compliance and implementation.
• Provide guidance to Clinical Operations and GCP-related departments on regulations and risk management.
• Identify and manage risks in clinical trial activities.
• Coordinate resolution of findings and non-compliant issues including CAPA plans.
• Participate in the review of drug safety practices.
• Conduct and assist in internal audits of systems, processes, vendors, and computer system validation.
• Identify need for and conduct external audits of investigator sites, IRBs, CROs, and clinical labs.
• Oversee the audit response process for Investigator Site and CRO audits.
• Provide functional review of clinical protocols, Informed Consent Forms, and Clinical Study Reports.
• Assist and advise with training QA and clinical staff for GCP.

Required qualifications

• BS in a life science
• 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
• Well organized, self-motivated and independent work style
• Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management
• Ability to handle multiple project issues with time demands or incomplete information
• Understanding of the drug and biologic development and clinical research processes
• General understanding of non-clinical research and manufacturing processes including terminology
• Ability to travel domestic and international

Nice to have

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

Benefits

• Bonus
• Equity
• Benefits

About the company

Remix Therapeutics is a clinical-stage biopharmaceutical company pioneering a new class of medicines that modulate RNA splicing to address the underlying biology of disease. Headquartered in Watertown, MA, Remix is advancing its pipeline with the urgency and scientific rigor that patients deserve.