---
title: 'Quality Systems Manager/Senior Manager at Obsidian Therapeutics'
canonical: 'https://feeny.ai/job/quality-systems-manager-senior-manager-obsidian-therapeutics-bedford-vxx8rmqffbpa'
type: 'job'
last_seen: '2026-09-05'
---

# Quality Systems Manager/Senior Manager at Obsidian Therapeutics

- **Company:** Obsidian Therapeutics
- **Location:** Bedford, MA
- **Compensation:** $117k–$165k
- **Work type:** hybrid
- **Posted:** 2026-09-04
- **Last confirmed live:** 2026-09-05
- **Apply:** https://job-boards.greenhouse.io/obsidiantherapeutics/jobs/6181144004

## Job description

## About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA.   Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We are looking for a highly motivated Quality Systems Manager/Senior Manager, with a strong background in owning, maturing, and modernizing scalable Quality Systems.

A key contributor within Quality Systems & Compliance, you’ll implement Obsidian’s eQMS and serve as process owner for critical quality system processes including Change Control, Product Complaints, Deviations, CAPA, Vendor Notifications, and Quality Management Review, as we advance our first clinical stage autologous cell therapy program targeting solid tumors.

As a member of our Technical Operations team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a clinical-stage company with field-leading advisors, best-in-class partners, and an experienced team.

This is a Hybrid role based out of our Bedford, MA location.

You Will...

Core responsibilities

- Manage the Quality Management System (QMS), serving as process owner for Change Control, Product Complaints, Deviations, Corrective and Preventive Actions (CAPA), Vendor Notifications, and Quality Management Review (QMR).
- Ensure quality system processes remain compliant with applicable FDA, ICH, and GxP requirements while maintaining inspection readiness.
- Author, revise, and maintain SOPs, forms, templates, training materials, and other quality system documentation.
- Monitor quality system performance, identify systemic process issues, and drive continuous improvement initiatives.
- Support internal audits, external audits, and regulatory inspections.
- Serve as the Quality business lead for eQMS selection, implementation, validation, deployment, and ongoing optimization.
- Partner with Digital Solutions & Technology, Regulatory Affairs, Manufacturing, Supply Chain, QC, and QA stakeholders to define business requirements and future-state workflows.
- Lead process mapping, workflow design, system configuration, validation activities, data migration, training, communication, and change management efforts to ensure successful adoption.
- Establish and maintain governance processes, SOPs, and administration practices supporting ongoing system enhancements and continuous improvement.
- Own the Change Control program, including governance, process monitoring, effectiveness assessments, Change Control Review Board (CCRB) activities, and continuous improvement initiatives.
- Ensure deviations, investigations, CAPAs, product complaints, and vendor notifications are managed in a timely, compliant, and risk-based manner.
- Provide coaching and guidance to investigation owners on root cause analysis, risk assessment, and effective problem-solving methodologies.
- Monitor quality event closure timelines, extensions, recurring trends, and overall process effectiveness.
- Develop and maintain quality metrics, dashboards, scorecards, and executive-level reporting to support Quality Management Reviews.

You Bring...

Core Qualifications

- Bachelor's degree and 6+ years of experience in QA within clinical late stage biopharmaceutical environments
- 3+ years of direct process ownership or administration of quality systems, including change control
- Successful experience leading or playing a significant role in implementation of an eQMS
- Management of systems such as Veeva, MasterControl, TrackWise, or equivalent platforms
- Strong working knowledge of FDA, EU GMP, ICH, and applicable GxP regulations
- Excellent planning, coordination, and time management skills
- Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
- Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization
- Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes
- Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.
- Flexible - adapts to change in a fast paced, rapidly developing environment
- Curious and humble – seeks and welcomes input/expertise of others, continuous learner
- Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.

Bonus Qualifications

- Experience leading full eQMS implementation as business process owner
- Strong project management and organizational skills
- Ability to influence cross-functional teams without direct authority

Obsidian is committed to equitable and transparent pay practices.

The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.

Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.

Anticipated Base Salary Range $117,000—$165,000 USD

Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

## About Obsidian Therapeutics

## Company Overview
- **One-liner**: Obsidian Therapeutics is a biotechnology company pioneering engineered tumor‑infiltrating lymphocyte (TIL) therapies for solid tumors using its proprietary cytoDRiVE® platform to regulate protein expression with an FDA‑approved small molecule.
- **Entity Type**: Private (later‑stage; most recent Series C closed April 2024; entered a merger agreement with Galera Therapeutics and a concurrent $350M private placement announced in 2025)
- **Headquarters**: Cambridge, Massachusetts, United States (with a laboratory facility in Bedford, MA)
- **Founded**: 2015
- **Founders**: Not publicly disclosed on the company website; the leadership team includes a CEO, CTO, CMO, CFO, and Chief People Officer.

## Core Business
- **Primary industry**: Biotechnology (cell and gene therapy, oncology)
- **Target customers**: B2B / healthcare – primarily developing therapies for patients with solid tumors; partners with academic centers, clinical sites, and biopharma companies.
- **Mission / purpose statement**: “Pioneering engineered cell and gene therapies to deliver transformative outcomes for patients.” The company emphasizes urgency for patients and a commitment to safer, more effective TIL therapies.

## Products & Services
- **cytoDRiVE® Platform**: A proprietary technology that uses drug‑responsive domains (DRDs) to control the function of therapeutic proteins inside cells using an FDA‑approved small‑molecule ligand. The platform can be applied to membrane‑bound, intracellular, or secreted proteins.
- **OBX‑115 (cytoTIL15)**: Lead clinical‑stage engineered TIL cell therapy that expresses membrane‑bound IL‑15 (mbIL15) to enhance TIL persistence and activity without the need for co‑administered IL‑2. Currently in Phase 1 trials for metastatic melanoma and non‑small cell lung cancer (NSCLC). (ClinicalTrials.gov identifiers: NCT05470283, NCT06060613)
- **Pipeline**: Early‑stage research exploring OBX‑115 in combination with PD‑1 inhibitors, as well as additional undisclosed cytoTIL programs for other solid tumor indications.

## Market Standing
- **Valuation / Market Cap**: Not disclosed (privately held).
- **Key Metric – Total Funding**: $325 M in known equity rounds (Series A: $49.5 M led by Google Ventures, 2017; Series B: $115 M led by The Column Group, 2021; Series C: $160.5 M led by Wellington Management, 2024). Additionally, a $350 M private placement was announced in connection with a merger agreement with Galera Therapeutics (the transaction is ongoing).
- **Notable Investors / Partners**: The Column Group, Wellington Management, Google Ventures (GV), and 14 other investors across rounds.
- **Growth Signals**: Lead program OBX‑115 has completed enrollment in a single‑center melanoma study and is now enrolling in a multi‑center Phase 1 study (Agni‑01) for melanoma and NSCLC. The company acquired Galera Therapeutics and secured significant additional capital via a concurrent private placement, indicating strong investor confidence. Headcount as of mid‑2025 is ~92 employees, with a recent slight decline (-11.7% YoY) typical of a focused R‑stage biotech. Active job postings increased 100% month‑over‑month, suggesting renewed hiring.

## Competitive Advantages
- **cytoDRiVE® Platform**: Provides tunable, on‑demand control of therapeutic proteins using an approved small molecule – a unique differentiator that can improve safety and efficacy in cell therapy.
- **Focus on TIL therapy**: Targets the challenging solid tumor space where conventional TIL therapy is limited by IL‑2 toxicity. OBX‑115 removes the need for high‑dose IL‑2, potentially broadening patient access.
- **Proprietary DRD library**: A growing, internally discovered set of drug‑responsive domains that enable rapid optimization for different cell types and protein classes.
- **Well‑funded and experienced team**: Backed by top‑tier investors and led by executives with deep cell therapy and oncology expertise.

## Strategic Focus
- **Clinical execution**: Advancing OBX‑115 through Phase 1 trials in melanoma and NSCLC, with plans to expand indications and combinations.
- **Platform expansion**: Applying cytoDRiVE® to other cell and gene therapy modalities (e.g., CAR‑T, TCR, gene editing) through partnerships and internal programs.
- **Manufacturing and scaling**: Building internal capabilities in process development, quality control, and supply chain to support commercial‑scale production.
- **Talent growth**: Active hiring across R&D, quality, manufacturing, and IT (8 open positions at time of data pull), with a focus on hybrid roles in Cambridge and Bedford, MA.

## Why Work Here
- **Culture**: The company describes itself as collaborative, curious, and authentic, with a strong sense of urgency to deliver therapies to patients. Emphasis on “no silos or hierarchies” and mutual respect.
- **Work model**: Hybrid (Cambridge, MA and Bedford, MA). Some roles may offer remote flexibility; most job postings specify hybrid.
- **Notable benefits**:
  - Employee stock options, 401(k) with HSA options.
  - Flexible time off (unlimited PTO policy).
  - 6 weeks fully paid bonding leave for new parents, plus fully paid medical maternity leave.
  - Generous health/dental coverage with low out‑of‑pocket costs and an annual HSA contribution.
  - Perks: gym, massage therapy, and meditation reimbursements; company‑sponsored lunches and social events.
  - Professional development: mentorship, training programs, tuition reimbursement, and career matrices for planning growth.
- **Engineering / science culture**: Strong cross‑functional collaboration between research, process development, quality, and clinical teams. The company values diversity and inclusion and reports gender pay equity.

## Sources
1. [obsidiantx.com](https://obsidiantx.com/) – Company overview, platform, pipeline, and career page
2. [obsidiantx.com/about-us](https://obsidiantx.com/about-us/) – About Us, management team, vision
3. [obsidiantx.com/join-our-team](https://obsidiantx.com/join-our-team/) – Culture, benefits, open positions
4. [linkedin.com/company/obsidian-therapeutics](https://www.linkedin.com/company/obsidian-therapeutics) – Employee count, funding, headcount trends, recent departures
5. [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05470283) – OBX-115 melanoma study
6. [clinicaltrials.gov](https://classic.clinicaltrials.gov/ct2/show/NCT06060613) – OBX-115 Agni-01 study

## Other roles at Obsidian Therapeutics

- [Cell Orchestration Manager/Senior Manager](https://feeny.ai/job/cell-orchestration-manager-senior-manager-obsidian-therapeutics-bedford-dqw9f7h63y87) — Bedford, MA
- [Director/Senior Director, G&A Digital Business Partner](https://feeny.ai/job/director-senior-director-g-a-digital-business-partner-obsidian-therapeutics-4fz5det3zr6d) — Cambridge, MA
- [Senior Manager/Associate Director, External Manufacturing](https://feeny.ai/job/senior-manager-associate-director-external-manufacturing-obsidian-therapeutics-hgkn17088xp8) — Bedford, MA
- [Director/Senior Director, Manufacturing Science and Technology (MSAT)](https://feeny.ai/job/director-senior-director-manufacturing-science-and-technology-msat-obsidian-c49qf00rk467) — Bedford, MA
- [General Interest Application - Obsidian Talent Community](https://feeny.ai/job/general-interest-application-obsidian-talent-community-obsidian-therapeutics-r3k8fnqhwtmp) — Cambridge, MA