[Remote] Executive Director, CMC Quality Assurance at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Experience leading and building a comprehensive Quality Assurance (QA) team to support development, manufacturing, and regulatory approval of biologic products
Expertise in executing and overseeing QA processes for global GMP and GLP compliance
Experience working closely with Technical Operations, Supply Chain, and cross-functional teams to meet biologic and device-specific global regulatory requirements
Experience ensuring the organization is inspection-ready at all times
Experience with combination product drug delivery systems
Expertise in leading QA efforts for combination products
Experience collaborating and influencing CDMOs, laboratory, and pack/label vendors
Ability to work remotely within the United States

Responsibilities

Develop and execute the company’s QA strategy across drug and device development and manufacturing
Lead and scale the QA team, including specialists in pharmaceutical and medical device quality
Ensure compliance with FDA, EMA, and other global regulatory requirements for combination products as applicable to Dianthus clinical studies (21 CFR Part 210, 211, 4 & 820, ISO 13485, etc.)
Oversee the Event (deviation, complaint, issue) and Corrective/Preventive Action (CAPA) process
Support the Quality Compliance Sr. Director with supplier and contract manufacturer audits, qualification, and ongoing performance monitoring
Guide technical development quality oversight—provide quality input to process development, technology transfer, comparability and stability strategies; approve key technical protocols and reports
Represent QA on governance forums (Change Review Board, Inventory & Operations – I&OP, CMC Team Review, Design Review Committee) and during health authority inspections as the primary product quality contact
Support regulatory submissions (IND, BLA, IDE, PMA) and serve as QA lead on submission reviews
Collaborate cross-functionally with Clinical, Regulatory, CMC, and Engineering teams to embed quality in a phase-appropriate manner
Provide QA support to nonclinical studies as needed (e.g. perform GLP audit of toxicology study protocols and reports)

Skills

Key technologies and capabilities for this role

CMC Quality AssuranceGMP ComplianceGLP ComplianceQuality Assurance LeadershipCombination ProductsDrug Delivery SystemsRegulatory ComplianceBiologics ManufacturingVendor ManagementInspection ReadinessSupply Chain Quality

Questions & Answers

Common questions about this position

Is this role remote-friendly?

Yes, the company is open to candidates working remotely within the United States.

What experience is required for this role?

The role requires experience with combination product drug delivery systems and expertise in leading QA efforts, along with the ability to collaborate and influence CDMOs, laboratories, and pack/label vendors.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like?

Dianthus is building a culture of individuals who hold core principles at the center of operations to elevate patient care, within a rapidly growing virtual organization.

What makes a strong candidate for this role?

A strong candidate will have experience ensuring global GMP and GLP compliance, working with cross-functional teams on biologic and device-specific regulatory requirements, and keeping the organization inspection-ready at all times.

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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