Position Title

Compliance Specialist

 

Vaccinex is a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases with unmet medical needs, including neurodegenerative diseases, cancer and autoimmune disorders. We believe we are the leader in the field of semaphorin 4D (SEMA4D) biology, and that we are the only company evaluating SEMA4D blockade as a potential treatment for neurodegenerative diseases, cancer or autoimmune disorders. Vaccinex has also developed a proprietary antibody discovery platform, ActivMab®, that enables efficient mammalian cell based expression of a library of human antibodies using viral vectors. In addition, this fusion protein technology enables the direct incorporation of conformation-dependent multipass membrane proteins, such as GPCRs and ion channels, into the viral membrane.

 

Description

The Compliance Specialist, is responsible for executing tasks to achieve and maintain compliance with cGMP, GLP, and GCP requirements at Vaccinex by maintaining and managing electronic documents, records, and data bases in support of regulatory submissions; participation in the planning and scheduling of appropriate training for Vaccinex personnel; planning and scheduling both internal and external audits designed to assure the quality of work and products associated with both internal and external efforts; and by preparing and/or assisting in the preparation of standard operating procedures.

 

Responsibilities

  1. Maintain an electronic documentation management system (DMS) compliant with FDA regulations and expectations, building on the existing Vaccinex system.
  2. Manage update of existing electronic DMS and implement new systems as required.
  3. Manage SOPs for use of the document system, including procedures for change control, deviation management and computer system change control.
  4. Conduct periodic review of SOPs and other documents to ensure they are current.
  5. Train personnel in the use of the document control system and assist in the generation of SOPs by Vaccinex personnel.
  6. Maintain and control access to the archive of all documents and records as required in an FDA-regulated environment.
  7. Maintain various quality systems and regulatory databases such as document change control and deviations.
  8. Track and review equipment logbooks, calibration and maintenance logs, etc.
  9. Ensure the timely review and approval of controlled documents by tracking and coordinating the review process in a proactive fashion.
  10. Maintain a records management system compliant with cGMP, GLP, and GCP regulations and expectations building on the existing Vaccinex system.
  11. Maintain training programs and training records.
  12. Participate in the planning and scheduling of internal and external audits.

 

Qualifications

  1. BS/BA degree in biological or physical sciences, or equivalent combination of education and experience, is required.
  2. At least 5 years in the regulated bio/pharmaceutical industry and at least 3 years of experience with Quality Assurance/Quality Systems is required.
  3. Scientific technical background with an emphasis on skills and know-how related to the manufacture, laboratory testing, and release of therapeutic biologic products (e.g., therapeutic monoclonal antibodies, vaccines) in the biopharmaceutical industry is strongly preferred.
  4. Excellent attention to detail is a must have.
  5. Strong interpersonal and team skills; ability to manage multiple initiatives and projects simultaneously is required.
  6. Excellent written and oral communication skills; ability to work independently and as a team member; demonstrated strong leadership skills is required.
  7. Must be competent in computer programs such as Microsoft Word, Microsoft Excel, Microsoft PowerPoint; experience with EDMS software is strongly preferred.
  8. Familiarity with computer system validation and change control is strongly preferred.

 

Please Note: Due to the high volume of responses, only inquiries from qualified candidates can be addressed.

No telephone inquiries or recruiters, please.

Vaccinex, Inc. is an equal opportunity employer.

Please send resume via e-mail to resume@vaccinex.com.