Abata Therapeutics

Director, Computer System Validation - Quality Assurance (CSV QA)

Remote

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries

Requirements

Candidates should possess a Bachelor’s degree in Computer Science, Information Systems, or a related field, with a minimum of 8 years of experience in Computer System Validation (CSV) within a regulated environment, preferably in the pharmaceutical or biotechnology industry. Strong knowledge of GxP regulations, including 21 CFR Part 11, is essential, along with experience in leading and managing validation projects.

Responsibilities

As the Director, Computer System Validation - Quality Assurance (CSV QA), you will lead and manage the CSV QA function, ensuring GXP computer systems are validated in compliance with relevant regulatory requirements. You will develop and implement CSV strategies, policies, and processes, oversee the planning and execution of validation activities, collaborate with cross-functional teams, lead risk mitigation efforts, and drive improvements in CSV and data integrity processes. Additionally, you will ensure validation documentation is maintained in compliance with regulatory requirements.

Skills

Computer System Validation
CSV
GXP
Validation Strategies
Regulatory Compliance
SDLC
Risk Assessment
Data Integrity
Process Improvement
Cross-functional Collaboration

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.

Key Metrics

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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