Senior Director, GCP Quality & Compliance

Remix Therapeutics; Watertown (MA); On-site; USD 230,000 - 281,000; Full time

Job summary

Remix Therapeutics, a clinical-stage biopharmaceutical company pioneering RNA splicing therapies, seeks a GCP Quality Assurance leader in Watertown, MA. You will oversee GCP activities across sponsored trials, ensuring SOP alignment with US FDA, ICH, GLP and ICH E6 standards, while guiding Clinical Operations and QA teams.

You will drive risk-based quality programs, coordinate CAPAs, support drug safety reviews, and participate in internal and external audits.

Qualifications

• BS in 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; well organized and independent.
• Excellent interpersonal skills with negotiation and conflict management.

Responsibilities

• Write and/or review SOPs to ensure regulatory compliance across the organization.
• Provide guidance to Clinical Operations and other GCP departments on regulatory interpretation.
• Identify and manage risks in clinical trial activities and monitor CAPA plans.
• Coordinate resolution of findings/non-compliance and oversee CAPA processes.
• Assist in external audits (investigator sites, CROs, central IRBs).
• Oversee audit responses for Investigator Site and CRO audits/inspections.
• Review etc. regulatory documents (protocols, ICFs, CSRs) for compliance.
• Travel domestically and internationally as required.

Skills

GCP auditing

Regulatory compliance

Clinical operations

Communication skills

Risk management

Cross-functional collaboration

Time management

Education

BS in life science

Job description

Remix Therapeutics, a clinical-stage biopharmaceutical company pioneering RNA splicing therapies, seeks a GCP Quality Assurance leader in Watertown, MA. You will oversee GCP activities across sponsored trials, ensuring SOP alignment with US FDA, ICH, GLP and ICH E6 standards, while guiding Clinical Operations and QA teams.

You will drive risk-based quality programs, coordinate CAPAs, support drug safety reviews, and participate in internal and external audits.