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Manager, Quality Assurance

Location:
Cleveland, OH
Company:
Abeona

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Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.

Abeona is looking for a Manager, Quality Assurance, to join our team in Cleveland, Ohio. The successful candidate will be responsible for building and leading QA policy and procedures including authoring new training policies, SOPs and programs for company personnel, assuring compliance with existing policies and supporting the mission of Quality Assurance to Abeona’s overall benefit. The Manager, Quality Assurance may have additional specialized responsibilities commensurate with experience and training focused on internal and or external auditing, statistical analytics, archival operations, surveillance and monitoring protocol designs and their execution, etc.

Essential Duties and Responsibilities

  • Supports QA aspects including: Document Control, CAPA, Deviations/Investigations, Audits, Inventories Oversight; Training, or other key function and cross-train to support other functions.
  • Engage in the the Document Control process such that it is adequately maintained to keep track of current documents and archives, including review cycles and training new and existing staff in proper Document Control procedures and Change Control.
  • Participate in regular meetings with the appropriate departments to develop and/or improve processes.
  • Participate in the Abeona CAPA process.
  • Support interactions with the FDA and other regulatory agencies, when required.
  • Independently address and report on daily operational issues, as needed.
  • Enhance skills via regular training and continuing education, including professional society membership/participation.
  • Responsible for new hire employee training, employee development/guidance and conducting performance reviews in a timely and objective manner

Qualifications

  • Bachelor’s degree in a biological science, epidemiology, statistics or another health or science related discipline or relevant engineering degree and related work experience in quality and/or regulatory systems operation.
  • Have at least 5 years of experience in Quality Assurance supporting manufacturing and characterization of small molecule drug substance for pre-clinical and clinical use.
  • Significant work experience using standard MS Office software and experience with statistical analysis software programs.
  • Must be easily adaptable to changing priorities and deadlines, be well organized, articulate, and possess good writing skills.

Other Skills/Abilities

  • Working knowledge of GLP, GDP, GCP and GMP regulations and their relevant ISO counterparts and ICH Guidelines.
  • High level of proficiency with Microsoft Office programs, statistical software and computer data entry and database management.
  • Advanced communication and organizational skills.
  • Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
  • Attention to details and accuracy.
  • Ability to read, analyze, and interpret technical procedures and/or government documents.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required.

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