HobokenRecruiter Since 2001
the smart solution for Hoboken jobs

Sr./Manager, Quality Assurance

Company: Axsome Therapeutics, Inc.
Location: New York
Posted on: November 12, 2019

Job Description:

DESCRIPTION:Axsome Therapeutics is currently searching for a Quality Assurance Manager to provide quality oversight of Axsome's GxP programs. 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.
JOB SUMMARY: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.REQUIREMENTS:
    • 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".

Keywords: Axsome Therapeutics, Inc., Hoboken , Sr./Manager, Quality Assurance, Executive , New York, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Care Manager II (RN)
Description: Description: Position Purpose: Perform care management duties to assess, plan and coordinate all aspects of medical and supporting services across the continuum of care for select members to promote quality, (more...)
Company: Centene Coproration
Location: Scranton
Posted on: 12/6/2019

Accounting Research Manager
Description: Reference : 19-03452 Title : Accounting Research Manager Location : Newark, NJ Experience Level : Start Date / End Date : 11/05/2019 / 05/05/2020 Description Accounting Research Manager Primary responsibilities (more...)
Company: Crossfire Consulting
Location: Newark
Posted on: 12/6/2019

Commercial Lines Account Manager
Description: The Commercial Lines Account Manager candidate needs to be a self-starter, well organized, highly detailed, possess excellent written and verbal communication skills as well as having a solid commercial (more...)
Company: Patra Corp
Location: Allentown
Posted on: 12/6/2019

Manager of Donor Relations and Travel
Description: The NJSO is New Jersey's premier performing arts organization, with concert series in six venues around the state and robust education and community engagement programs. The Manager of Donor Relations (more...)
Company: New Jersey Symphony Orchestra
Location: Newark
Posted on: 12/6/2019

Sanitation Manager
Description: Sanitation ManagerManufacturing EnvironmentDAMASCUS BAKERIES is a 3rd Generation Bakery founded in 1930. -We have three baking facilities in Brooklyn, NY, Newark, NJ, Clifton, NJ. Our products include (more...)
Company: Damascus Bakery
Location: Newark
Posted on: 12/6/2019

Director, Skills Accelerator Learning Development
Description: Director, Skills Accelerator Learning Development - Prudential Financial ga Cookie Value Careers-Job Search-Job DetailsJob Description - Prudential Financial Human Resources WT FPC Cookie Value Skip (more...)
Company: Prudential Financial, Inc.
Location: Newark
Posted on: 12/6/2019

Senior Director Analytical RD REMOTE
Description: Company Overview Esperion is a small company doing big things. Our innovative team of lipid management experts is committed to leveraging its understanding of cholesterol biosynthesis to develop innovative (more...)
Company: Esperion - The Lipid Management Company
Location: Trenton
Posted on: 12/6/2019

Corporate Strategy Manager
Description: Feel Good Careers Sabra Dipping Company br br Sabra started at a small factory in Astoria, New York, but we always knew we were onto something big. As a joint venture between Strauss Group and PepsiCo, (more...)
Company: Sabra Dipping
Location: White Plains
Posted on: 12/6/2019

Clinical Director - Registered Nurse (RN)
Description: Job DescriptionClinical Director RN Aveanna Healthcare, the largest pediatric home health care company in the U.S., is hiring a Clinical Director to supervise all clinical services of the Health Care (more...)
Company: Aveanna Healthcare
Location: Hackensack
Posted on: 12/6/2019

Information Risk Manager
Description: Our strength is built on our ability to work together. Our diverse backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and (more...)
Company: Cognizant
Location: Jersey City
Posted on: 12/6/2019

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Hoboken RSS job feeds