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Quality Systems Manager

Department: Quality Systems
Reports to: Director, Quality Systems
Location: Framingham, MA

Summary of job description:

Reporting to the Director of Quality Systems, this position will be responsible for the management of quality systems at all Replimune locations.  This position will be located at the Framingham, MA location.

 

Key responsibilities:

  • Support day-to-day operations of the Quality Systems department.
  • Track and trend compliance paperwork (training, audits, deviations, change controls, both internal and external)
  • Manage and store all controlled documents.
  • Support the Electronic Document Management System (EDMS) as needed.
  • Adhere to company documentation policies and maintaining documentation systems as required.
  • Develops Standard Operating Procedures and other quality related documents.
  • Process documents in electronic Documentation Management System (eDMS)
  • Develops/Formats Standard Operating Procedures and other quality related documents.
  • Review records and documents, for completeness and compliance with global regulations.
  • Create standard operating procedures to define and improve quality system functions.
  • Authority to approve written procedures and other documents
  • Lead and participate in continuous improvement initiatives.
  • Assist with employee “on-boarding” training on general quality specific procedural requirements.
  • Participate in the internal auditor program.
  • Create and modify user groups, training items, curricula, group trainings and assignments.
  • Conduct periodic review and audits of Quality Systems.
  • Monitor, report and assist with preparation of QMS metrics.
  • Support GxP operations and help to ensure state of inspection readiness.
  • Assist in the validation and implementation of computerized systems spanning GxP, such as:
    • electronic Learning Management System (eLMS)
    • electronic Document Management System (eDMS)
    • Quality Management System (eQMS)
  • Assist in the oversight and management of computerized systems.
  • Manage documents in support of GXP compliance and with global data integrity regulations.
  • Management/Oversight of the Training Program including conducting training as needed (on-boarding, refresher, inspection readiness, computer systems, etc.).
  • Identify, support and deploy QMS projects as required.
  • Manage and maintain alignment between local practices and global QMS principles.
  • Track closure of items associated with Quality Systems such as change control implementation activities, CAPAs plans, and effectiveness reviews.
  • Contribute to long range planning of Quality System related activities.
  • Promote and advance a Quality Culture.

Educational requirements:

  • Bachelor’s degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience.
  • A minimum of 5-7 years of relevant experience.

Other Skills & Experience:

  • Validation of computerized systems with applicable regulations preferred.
  • Excellent verbal and written communication skills in group or one-on-one settings.
  • Computer skills, e.g., Microsoft Office applications, EDMS.
  • Ability to work in a very dynamic environment with a clear sense of urgency.
  • Excellent organizational skills and attention to detail and accuracy.
  • Performs other related duties and ad hoc projects as required by position.


EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.


Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.