Senior Director, GCP Quality & Clinical Compliance

Remix Therapeutics; Watertown (MA); Sur place; USD 230 000 - 281 000; Plein temps

Résumé du poste

Remix Therapeutics, a Watertown, MA–based clinical-stage biopharmaceutical company, seeks a GCP Quality Assurance professional to manage development, maintenance and oversight of GCP activities for company-sponsored trials. You will ensure quality and regulatory compliance with SOPs, FDA/ICH requirements, and industry standards, while guiding clinical operations and audit activities.

The role involves internal and external audits, CAPA coordination, training, and collaboration with QA and

Qualifications

• BS in life science required.
• At least 10 years of direct GCP pharmaceutical/biotechnology experience.
• Solid understanding of GCP, GLP and ICH requirements (ICH E6).
• Excellent written and oral communications skills; organized and independent work style.
• Ability to travel domestically and internationally.
• Broad experience in product development, clinical operations, regulatory compliance and GCP auditing.

Responsabilités

• Write and/or review SOPs to assess consistency and regulatory compliance across the organization.
• Provide guidance to Clinical Operations and other GCP-related departments based on regulations.
• Identify and manage risks in clinical trial activities and monitor risk management activities.
• Coordinate resolution of findings/non-compliant issues, including CAPA plans.
• Participate in review of drug safety practices for trial compliance.
• Conduct internal audits (systems, processes, vendors, computer validation).
• Identify need for external audits (investigators, CI/IRBs, CROs, labs).
• Oversee audit response for Investigator Site and CRO audits/inspections and CAPA actions.
• Review clinical protocols, consent forms, study reports.
• Assist training QA and clinical staff on GCP as needed.
• Coordinate regulatory training needs and delivery for Clinical Operations.
• Escalate critical non-compliance issues to senior management.
• Perform root cause analysis and provide QA metrics for management.
• Oversee vendor oversight activities for clinical trials.
• Assist senior staff during regulatory inspections.
• Travel domestically and internationally.
• Other duties as required.

Connaissances

GCP auditing

Regulatory compliance

Quality assurance

Risk management

SOP development

Communication

Cross-functional

Formation

BS in life science

Description du poste

Remix Therapeutics, a Watertown, MA–based clinical-stage biopharmaceutical company, seeks a GCP Quality Assurance professional to manage development, maintenance and oversight of GCP activities for company-sponsored trials. You will ensure quality and regulatory compliance with SOPs, FDA/ICH requirements, and industry standards, while guiding clinical operations and audit activities.

The role involves internal and external audits, CAPA coordination, training, and collaboration with QA and