Location: New York, NY
Sr./Manager, Quality Assurance
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The Sr./Manager Quality Assurance is responsible for managing the vendor qualification and audit program to ensure GxP vendors are properly vetted and approved in compliance with regulations and internal procedures. In addition, this position manages and executes the vendor quality review process and GxP audit program (internal and external). This position liaises with internal clinical and CMC team members, and external vendors to coordinate the effective execution and compliance of GxP vendor qualification and oversight management. This position requires excellent communication skills, attention to detail, willingness to travel, and supervision of external consultants/auditors.
- Manage GxP Vendor Qualification and review process including assessing new vendor qualification requests for risk to GxP operations, determine GxP vendor qualification requirements (e.g. onsite audit, remote audit, questionnaire), and accept/reject vendors based on evaluation outcome.
- Conduct and/or coordinate vendor audits including laboratories, data management, contract manufacturers, software, and clinical CROs.
- Assess changes of existing approved vendors for qualification status impact and coordinate internal/external actions to update documentation/systems.
- Maintain the approved vendor list (AVL).
- Manage ongoing compliance assessments of vendors on the AVL.
- Manage the global GxP vendor audit program by maintaining the audit schedule, selecting audit teams, and performing/coordinating audits.
- Perform corrective action follow-up through to audit closure.
- Manage the internal audit program and conduct audits for internal systems/procedures.
- Select and manage external auditors and oversee completion of audit reports in a timely manner.
- Represent quality in internal and external meetings.
- Implement improvements to existing quality processes.
- Work with internal departments and vendors to facilitate investigations/troubleshooting to ensure a rapid and appropriate response to quality related matters.
- Ensure proper evaluation and completeness of internal and vendor corrective and preventive action plans (CAPA).
- Work with CMC to review and approve all documentation related to manufacturing, registration and validation activities (including change control (CC), material expiry and drug product release).
- Develop and conduct company-wide awareness training on the vendor qualification program.
- Maintain standard operating procedures (SOPs).
- Author and revise Quality System Documents.
- Monitor adherence to company policies and applicable regulations and provide leadership regarding quality interpretation of regulatory requirements.
- Assist in inspections by regulatory agencies and inspection readiness activities.
- Other duties as assigned.
- B.S./B.A. degree or higher in a scientific discipline.
- Three or more years of GxP vendor auditing experience.
- Excellent understanding of FDA regulations and GMP, GLP and GCP Guidelines.
- Extensive knowledge of regulations and standards requirements related to vendor qualification, audit, and oversight.
- Strong knowledge of Change Control systems.
- Willingness to travel up to 10%, but at times may be higher based on business needs.
- Preference to candidates with prior small company experience.
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results.
- Strong attention to detail and excellent organization skills.
- Excellent interpersonal skills and communication skills (both written and verbal).
- Strong leadership skills, self-motivated, adaptable to a dynamic environment.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Preference to energetic candidates with a desire to think “outside the box”.