Contract, Quality Assurance – Computer System Validation (QA CSV)

United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates must possess a Bachelor’s degree in a technical, scientific, or related academic discipline and a minimum of 6 years of experience in the pharmaceutical, biotechnology, or a related environment, combined with at least 3 years of experience in GxP Computer System validation, or equivalent education and experience. Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV (such as, GMP, GAMP, Part 11, Annex 11, ICH Q9, etc.) activities and compliance are required. Experience with SAP projects is essential.

Responsibilities

The Contract, Quality Assurance – Computer System Validation (QA CSV) will write and/or review and approve CSV documents, including Validation Plans, Functional Risk Assessments, and Application Design or Configuration Specifications, and drive/participate in meetings with key stakeholders. This role will serve as the QA CSV point of contact and Subject Matter Expert (SME) for validation activities, assist in quality reviews and QA vendor audits, manage external resources for CSV-related activities, review system master plans, perform GxP-related activities, ensure evolving validation requirements are applied, write or contribute to SOPs, and assist in the development of training materials. The incumbent will also liaise with IT and other cross-functional teams to develop GxP/Non-GxP deliverables and ensure compliance with regulatory requirements.

Skills

Computer System Validation

Validation Plans

Functional Risk Assessments

Application Design

Configuration Specifications

Test Scripts

Quality Risk Management

GxP Compliance

Regulatory Requirements

Vendor Audits

Change Controls

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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