---
title: 'Senior Director, GCP Quality at Remix Therapeutics'
canonical: 'https://feeny.ai/job/senior-director-gcp-quality-remix-therapeutics-watertown-ancn66bxrnf3'
type: 'job'
last_seen: '2026-10-24'
---

# Senior Director, GCP Quality at Remix Therapeutics

- **Company:** Remix Therapeutics
- **Location:** Watertown, MA
- **Posted:** 2026-10-15
- **Last confirmed live:** 2026-10-24
- **Apply:** https://job-boards.greenhouse.io/remixtherapeutics/jobs/4743975005

## Job description

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. Our lead program, REM-422, targets pre-mRNA splicing in oncology and represents a fundamentally differentiated approach to drug discovery. Headquartered in Watertown, MA, Remix is advancing its pipeline with the urgency and scientific rigor that patients deserve.

Position Summary:

The GCP Quality Assurance candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by company. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices.

Key Responsibilities:

- Write and/or review SOPs to assess consistency and compliance with regulatory requirements/internal standards and determine/ensure effective implementation across the organization.
- Provide guidance to Clinical Operations staff and other GCP-related departments, as applicable,  based on interpretation of current regulations to ensure best practices including risk based management.
- Provide guidance with the identification and management of risks in clinical trial activities and monitor/evaluate risk management activities.
- Work closely with Clinical Operations and other GCP-related departments, as applicable, to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues in a timely manner, including approval of corrective action/preventative action (CAPA) plans, as necessary.
- Participate in the review of drug safety practices for clinical trial compliance.
- Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation).
- Identify need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).
- Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process.
- Provide functional review of clinical protocols, Informed Consent Forms,  Clinical Study Reports and other clinical trial related documents.
- Assist and advise with training QA and clinical staff as necessary for GCP.
- Collaborate with applicable departmental heads to identify clinical trial and regulatory training needs of Clinical Operations (and other Clinical trial members) based on regulatory changes, process/system changes, audit findings, trends, , and assist in coordinating the training to meet the needs.
- Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.  As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management.
- Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.
- Provide guidance with the development and management of key vendor oversight activities for clinical trials and monitor/evaluate the oversight activities.
- Assist senior staff during regulatory inspections.
- Ability to travel domestic and international.
- Other duties, as required.

Qualifications:

- BS in a 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 A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
- Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
- The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
- Understanding of the drug and biologic development and clinical research processes
- General understanding of non-clinical research and manufacturing processes including terminology
- Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing

Salary Range

$230,000 - $281,000 USD

This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable.  Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.

## About Remix Therapeutics

## Company Overview
- **One-liner**: Clinical-stage biotechnology company developing first-in-class oral small molecule therapies that reprogram RNA processing to address previously undruggable drivers of cancer and other diseases.
- **Entity Type**: Private (Venture-backed; merged with Passage Bio in June 2026 with a concurrent $100M private placement)
- **Headquarters**: Watertown, Massachusetts, United States
- **Founded**: 2018
- **Founders**: Peter Smith, PhD

## Core Business
- **Primary industry**: Biotechnology – RNA-targeted therapeutics, oncology
- **Target customers**: B2B (pharmaceutical partners like Roche and Johnson & Johnson) and B2C (patients with high-unmet-need cancers, served through healthcare providers)
- **Mission or purpose statement**: “Reprogramming RNA to transform patients’ lives” – focused on modulating RNA processing to address disease drivers at their origin

## Products & Services
- **REM‑422**: First-in-class, orally available small molecule mRNA degrader targeting the historically undruggable transcription factor MYB. Currently in Phase 1 clinical trials for acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (HR‑MDS), and adenoid cystic carcinoma (ACC). Granted FDA Fast Track designation for ACC.
- **REMaster™ Drug Discovery Platform**: Proprietary platform that designs small molecules to harness cellular RNA‑processing machinery, enabling modulation of gene expression for targets previously considered intractable. Used for internal pipeline and partnered programs.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (private company; post-merger valuation unknown)
- **Key Metric**: Total funding ~$240.7M (including a $100M private placement concurrent with the Passage Bio merger in June 2026). Annual revenue (2025 estimate): $3.2M (typical for a clinical‑stage biotech).
- **Notable Investors/Partners**:  
  - Investors: Surveyor Capital (Series B lead, $70M), Foresite Capital (Series A lead, $65M), The Column Group (Venture Round lead, $60M)  
  - Partners: Roche (collaboration for RNA‑processing modulators), Johnson & Johnson Innovative Medicine (multi‑year, three‑target oncology/immunology collaboration)  
- **Growth Signals**:  
  - Preliminary Phase 1 data for REM‑422 showed strong anti‑tumor activity and favorable safety in ACC  
  - FDA Fast Track designation for REM‑422 in ACC  
  - Merger with Passage Bio (June 2026) brings additional capital and pipeline synergies  
  - Active job postings up 200% month‑over‑month and quarter‑over‑quarter  
  - Headcount of 49 employees with a heavy concentration in research (43%)

## Competitive Advantages
- **Proprietary REMaster platform** uniquely enables oral small‑molecule modulation of RNA processing, expanding the druggable target space beyond traditional protein inhibition
- **First‑in‑class oral MYB mRNA degrader** (REM‑422) addresses a transcription factor long considered undruggable
- **Top‑tier pharma collaborations** with Roche and J&J validate the technology and provide non‑dilutive funding
- **Strong scientific leadership** (CEO/co‑founder Peter Smith, PhD, formerly CSO at H3 Biomedicine, where he advanced three molecules to the clinic)

## Strategic Focus
- Advance REM‑422 through Phase 1 trials across multiple MYB‑driven cancers (AML, HR‑MDS, ACC) and expand into additional solid tumors
- Leverage the REMaster platform to discover new RNA‑processing modulators for oncology and immunology
- Deepen existing pharma partnerships and seek new collaborations to accelerate pipeline growth
- Integrate the recently merged Passage Bio assets and utilize the $100M private placement to fund clinical development

## Why Work Here
- **Culture**: Values-driven environment centered on “True to Our RNA” (scientific integrity), “Courageous Curiosity” (bold innovation), and “Remixing Together” (collaboration and mutual support). Employees describe a flat, science‑first culture where diverse perspectives are welcomed.
- **Work model**: Hybrid? While not explicitly stated, the company has three offices in the Boston area (Watertown HQ, One Kendall Square Cambridge, and another Cambridge location). Lab‑based roles are likely on‑site; corporate roles may offer flexibility.
- **Perks & environment**: Small company (~49 people) with the energy of a startup but backed by significant funding and pharma partnerships. Employees share a strong sense of mission to bring new therapies to patients with few options. “We take our work seriously but not ourselves.”
- **Growth opportunity**: Rapidly advancing clinical pipeline and post‑merger expansion offer career advancement in a high‑visibility biotech. Recent ramp‑up in hiring (3 active postings for senior leadership roles like VP of Program Team Lead, VP of Biostatistics, and Senior Manager of Strategy & BD) signals scaling.

## Sources
1. [Remix Therapeutics Home](https://www.remixtx.com/)
2. [Remix Therapeutics About Us](https://www.remixtx.com/about/)
3. [Remix Therapeutics Join Us](https://www.remixtx.com/join/)
4. [Remix Therapeutics LinkedIn](https://www.linkedin.com/company/remix-therapeutics)
5. [Remix Therapeutics Greenhouse Careers](https://job-boards.greenhouse.io/remixtherapeutics)

## Other roles at Remix Therapeutics

- [Associate Director, Clinical Data Management](https://feeny.ai/job/associate-director-clinical-data-management-remix-therapeutics-watertown-qq070g410ywh) — Watertown, MA
- [Head of Medical Affairs](https://feeny.ai/job/head-of-medical-affairs-remix-therapeutics-watertown-x0b0ddpp9nnc) — Watertown, MA
- [Vice President/Senior Director, Nonclinical Drug Safety & Toxicology](https://feeny.ai/job/vice-president-senior-director-nonclinical-drug-safety-toxicology-remix-hcv58wta0q0b) — Watertown, MA
- [Vice President, Clinical Development](https://feeny.ai/job/vice-president-clinical-development-remix-therapeutics-watertown-0ewyfa0bvx9g) — Watertown, MA