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Senior Associate, Clinical Quality Assurance – Woburn, MA

Replimune is pioneering a new generation of cancer treatments called oncolytic immunotherapies. These cleverly designed therapeutics combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, generating a powerful patient-specific, systemic immune response.

 

Summary of job description:

Reporting into the Manager, Clinical Quality Assurance, the Senior Associate, Clinical Quality Assurance will support and ensure that all systems and processes are compliant with good clinical practice (GCP) guidelines, standards, and regulations (FDA, MHRA, EMA, ICH). The Senior Associate, Clinical Quality Assurance will be responsible for assisting GCP QA and Quality Systems with Training, Document Control, tracking GCP elements of the Quality Management System (QMS), logistical support for Inspection Readiness activities, Project and clinical trial support, Vendor oversight; including audit support and audit closeout. The Senior Associate, Clinical Quality Assurance will ensure that all processes contributing to the performance of a clinical trial are established and conducted compliantly, troubleshoot escalated clinical trial issues, manage and maintain databases for the quality system, as well as prepare and assist in preparing annual reports and quality trending reports.

 

Key responsibilities:

  • Assist in the development and implementation of GCP quality standards, policies, and procedures that comply with applicable standards, regulations and guidelines for GCP globally.
  • Perform compliance review of clinical protocols, clinical study reports, investigator brochures and other clinical documentation
  • Assist with coordination and logistics for pre- and post-inspection and audit activities, including training, and functional area readiness
  • Assist with developing storyboards, along with functional areas and subject matter experts to be shared during audits for key processes and programs.
  • Work cross functionally to build and maintain inspection readiness content to ensure quick access to materials in the event of an inspection or audit
  • Represent CQA as single point of contact to assigned study teams including attending cross-functional study team meetings.
  • Manager GCP vendor, clinical site and TMF audits related to assigned study teams including tracking all findings, responses, CAPAs, etc.
  • Assist with implementation and maintenance of Electronic Document Management Systems. Assist with drafting processes and procedures to support EDMS.
  • Perform a variety of tasks, duties and responsibilities as assigned from time to time

 

Educational requirements:

  • S. degree in life sciences or equivalent

 

Experience and skill requirement:

  • Minimum 2 years related experience in GCP (Clinical Research, investigator site or Quality)
  • Strong interest in gaining technical knowledge of applicable GCP regulations and standards.
  • Ability to independently research compliance trends and regulatory authority expectations
  • Self-motivated with the ability to prioritize and identify critical compliance risks
  • Experience with EDC and EDMS preferred
  • Superb attention to detail and professional demeanor
  • Excellent communication and organizational skills, along with problem solving and conflict resolution
  • Proficient in MS Office (i.e. Word, Excel, PowerPoint), and Adobe Acrobat
  • Travel up to 20%


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.