Clinical Quality Assurance Manager – Woburn, MA
The Clinical Quality Assurance Manager will support and ensure that all Replimune systems and processes are compliant with good clinical practice (GCP) guidelines, standards, and regulations (FDA, MHRA, EMA, ICH). This role is responsible for assisting GCP Quality Assurance and Quality Systems with project and clinical trial support, document control and training. The successful candidate will also be responsible for vendor oversight, including audit support and audit closeout, tracking GCP elements of the Quality Management System (QMS) and assisting with the logistics of the Inspection Readiness activities. This role ensures all processes contributing to the performance of a clinical trial are established and conducted compliantly. The Clinical Quality Assurance Manager will troubleshoot escalated clinical trial issues, manage and maintain databases for the Quality System, and prepare and assist in preparing annual reports and quality trending reports.
- Assist the quality team in the development, establishment and maintenance of internal Quality Systems processes and procedures that comply with applicable standards, regulations and guidelines for GCP globally.
- 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 with departments to build and maintain inspection readiness content to ensure quick access to materials in the event of an inspection or audit.
- Work closely with the cross-functional teams to close gaps and improve compliance and inspection readiness capabilities.
- Vendor Audit Program: Assist with tracking GCP vendor and site audits, responses, CAPAs, etc.
- Electronic Document Management System (EDMS): Assist with implementation of platforms and assist with drafting processes and procedures to support the EDMS.
- Perform a variety of tasks, duties and responsibilities as assigned from time to time.
Educational and Skill requirements:
- Bachelor’s degree in Life Sciences or related field
- Minimum of 6 years related experience in GCP (Clinical Research, investigator site or Quality)
- Management / supervisory experience a plus
- Strong interest in gaining technical knowledge of applicable GCP regulations and standards
- Ability to independently research compliance trends and regulatory authority expectations
- Ability to prioritize and identify critical compliance risks
- Experience with EDC and EDMS preferred
- Superb attention to detail and professional demeanour required
- Excellent communication and organizational skills
- Proficiency in MS Office (Word, Excel, Outlook, PowerPoint) and Adobe Acrobat required
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.
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.