Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.
Axsome Therapeutics is seeking a Manager, QA Systems to support the development, implementation, and improvement of Axsome’s quality management systems for marketed products and late phase clinical programs. The Manager, QA Systems will also be responsible for ensuring compliance of Good Manufacturing Practices (GMP) and industry best practices across all work performed. This role reports into the Director, Quality Systems and Compliance.
This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
include, but are not limited to, the following:
- Support the development, implementation, and improvement of corporate quality management systems that support marketed product, and late phase clinical programs
- Assist with the management and development of Axsome’s electronic quality management systems, inclusive of deviation/corrective and preventive (CAPA), Product Quality Complaints, and Supplier Qualification
- Develop and implement a comprehensive supplier qualification program to ensure the selection of reliable and compliant vendors
- Conduct initial and ongoing assessments of suppliers to evaluate their capabilities, quality systems, and adherence to regulatory requirements
- Lead and manage the product quality complaints process, ensuring timely and thorough investigations of all complaints received
- Monitor Quality Systems via metrics for trends and notify management of events requiring immediate action
- Conduct or oversee GMP audits of external Contract Manufacturing Organizations (CMOs), contract testing laboratories and distribution centers to assure compliance with internal procedures and regulatory guidelines
- Conduct audits of internal processes and procedures for adherence to SOPs, company policies, and regulations/standards and ensure associated CAPA are closed according to established timelines
- Serve as an escalation point for quality issues with regards to investigations, nonconformances / deviations, and CAPAs
- Provide support in the review and approval of internal change controls
- Identify and address compliance issues and processes to ensure the QMS is maintained in a state of inspection readiness
- Author, review or revise Standard Operating Procedures (SOPs), Work Instructions (WI) and other controlled documents
- Follow through on corrective and preventive actions from deviations, OOS and product complaints
- Escalate serious compliance issues to senior management
- Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to management, as applicable
- Bachelor of science degree required, preferably in a scientific discipline
- At least 5 years’ experience working in QA/QC within the pharmaceutical or biotechnology industries
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
- Experience in either Product Quality Complaints or Vendor/Supplier Qualification
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Strong attention to detail and excellent organization skills
- Comfortable with independent decision making and assessing escalation points
- Strong interpersonal skills and communication skills (both written and oral)
- Willingness to travel as needed
The anticipated salary range for this role is $115,000 - $128,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
What We Do
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options.
Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians
