Document Control Manager

Posted on May 25,

Orna Therapeutics, Inc. is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional Document Control Manager to join our team. The ideal candidate will have experience with the management of GxP internal/external documentation, training program and additional functional activities. They must have a working knowledge of QMS and its responsibilities and be a self-starting problem solver who drives results through high compliance and a positive work style ensuring quality activities are carried out according to the regulatory requirements.

Responsibilities

  • Ensure quality activities are carried out according to the regulatory requirements and/or the internal QMS.
  • Drive Document Management System tasks to completion.
  • Assist in the execution of other QMS responsibilities as needed (i.e., CAPA, Change Control, Quality Events, etc.)
  • Assist in facilitating and conducting trainings related to the electronic document management system in coordination with QA/GxP Training.
  • Editing documents for consistent formatting and working with content owners to ensure quality document.
  • Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, and obsoleted within needed timeframes.
  • Follow up with others to ensure that records are completed and documented within established timeframes.
  • Execute Administrative tasks for Veeva Quality Vault or equivalent EDMS system including but not limited to user provisioning and periodic system updates/maintenance.
  • Be a self-starting problem solver who drives results through high compliance and a positive work style.
  • Additional responsibility for execution and maintenance (data entry, metric reporting, filing, archival) of assigned quality system.
  • Performs related duties as required.

Qualifications

  • Bachelor’s degree or equivalent experience.
  • At least 3 years of experience in the pharmaceutical/biotech industry. 7+ years of document management experience in a Quality Assurance related function.
  • Must have excellent abilities with intermediate MS office concepts such as Word Styles, cross-references, keep with next, section breaks, freeze panes, header/footer, and others.
  • Experience with Veeva Vault or other electronic document and quality management system is preferred.
  • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
  • Strong proofreading and document formatting skills which must include processing of controlled documents (new documents, revision, obsolescence, etc.)
  • Strong problem solving/analytical skills.
  • Ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.
  • Excellent written and verbal communication skills, strong organizational skills, strong negotiation, analytical and decision-making skills, and attention to detail
  • The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
  • Strong organizational skills, with the ability to handle multiple tasks.

Website: https://www.ornatx.com/

Orna Therapeutics, Inc. is an equal opportunity employer.