[Remote] Senior Specialist, Quality Management Systems - Document Control at Axsome Therapeutics Inc

United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Bachelor’s degree in a relevant discipline and a minimum of 3 years progressively responsible and relevant experience, preferably as part of a Quality organization, in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and/or education
Demonstrated knowledge and understanding of GMP regulations and document control standards
Demonstrated proficiency in formatting of controlled documents/procedures that are aligned with company style standards and templates
Ability to perform tasks relating to document control
Good interpersonal skills with the ability to handle conflict
Proficiency with Microsoft Office
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast-paced environment

Responsibilities

Actively contributes to the on-going support of the Quality EDMS, including assisting with the definition of business processes and user requirements; participating in EDMS usability and upgrade testing; and reporting issues to the project team to support and facilitate prompt resolution
Serves as Quality EDMS system administrator with responsibility for providing support for departmental end users, proposing continuous EDMS process improvements, and processing procedural documents in the EDMS
Plans and schedules development meetings with appropriate collaborating authors and department representatives
Works collaboratively with department representatives who author, execute, review, approve and retire procedural documents and ensures documents are tracked, properly formatted, and processed for biennial review
Liaises with Compliance Learning to provide support when processing documents in EDMS to ensure compliance with company standards and requirements
Ensures good documentation practices and adherence to regulatory and PTC standards
Supports audits and regulatory agency inspections by providing documents as requested
Performs other tasks and assignments as needed and specified by management

Skills

Key technologies and capabilities for this role

Quality Management SystemsQMSDocument ControlEDMSElectronic Documentation Management SystemSOPsWork InstructionsGxP ComplianceRegulatory Compliance

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

What are the main responsibilities of the Senior Specialist role?

The role involves administering the Quality EDMS, supporting end users, processing procedural documents, collaborating with cross-functional teams on QMS documents, ensuring good documentation practices, and supporting audits and inspections.

What skills or experience are needed for this role?

Key skills include experience with Quality Management Systems (QMS), Electronic Documentation Management Systems (EDMS), good documentation practices, regulatory compliance (GxP), cross-functional collaboration, and supporting audits and inspections.

What is the company culture like at PTC Therapeutics?

PTC cultivates an inclusive culture where everyone feels valued, respected, and empowered, welcoming candidates from all backgrounds to foster a strong sense of belonging.

What makes a strong candidate for this position?

A strong candidate has experience administering EDMS and QMS documentation, excels in cross-functional collaboration, ensures regulatory compliance and good documentation practices, and can support audits.

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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