Quality Systems Manager

Aspen Neuroscience is seeking a driven and collaborative Quality Systems Manager as a new addition to our team. Reporting to the Vice President, Quality Unit, this role is fully responsible for the management and administration of the company’s Quality Systems, including training and document control. We are looking for top talent with exceptional organization skills and a desire to learn and grow to join this highly dynamic and patient-focused team with a commitment to excellence.

Duties & Responsibilities

  • Manages document control and training management and processes to ensure GxP compliance with internal policies and external regulations
  • Supports the routing, review, approval, distribution, and archiving of new and revised controlled documents
  • Develops, revises, and reviews procedures and other controlled documents
  • Collaborates with cross-functional team members to author and revise controlled documents
  • Provides support during regulatory inspection • Prepares status reports for document control, training, and quality systems for Quality Management review
  • Manages, monitors, reviews, and approves quality events and associated workflows, including GxP documentation • Support vendor management program
  • Support validation activities for GxP systems
  • Perform new hire orientation and training
  • Perform data-entry and reconcile legacy and active training files
  • Oversee and support, in conjunction with Systems and applicable cross-functional teams, the management of company’s validated GxP computerized systems, including risk assessments

Education and Experience

  • Bachelor’s degree or a combination of relevant education and applicable job experience.
  • Minimum of 4 years’ experience within FDA regulated industry
  • Experience working with Electronic Documentation Management Systems (EDMS), Learning Management System (LMS), and Quality Management System (QMS)
  • Direct experience developing and maintaining document control, training management and quality management systems
  • Experience with cGMP regulated environment
  • Experience authoring SOPs, protocols, and reports

Job Specifications:

  • Excellent writing and editing skills with strict attention to detail to meet compliance requirements
  • Ability to work on multiple assignments in collaboration with cross functional team members
  • High level of initiative in a fast-paced environment.
  • Very detail-oriented and organized.
  • Ability to work in teams as well as independently.
  • Strong written and verbal communication skills.
  • Advanced Microsoft Office Skills

EEO and Employment Eligibility 

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.

Total Rewards and Culture 

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, gym membership, and other wellness perks.

For immediate consideration, apply here: https://app.trinethire.com/companies/21059-aspen-neuroscience/jobs/65089-quality-systems-manager

Please note that we at Aspen Neuroscience do not make determinations on who would be eligible for participation in clinical trials, and we do not offer tours of our laboratory. At this time, our therapy has not yet been used in humans and clinical trials have not begun.