Senior Associate, Quality Systems – Woburn, MA & Framingham, 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. We are currently adding 2 Sr. Associates, Quality Systems to our Woburn, MA location & 1 Sr. QA Associate to our Framingham, MA location.
Summary of job description:
This position provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.
- Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
- Participate in continuous improvement initiatives.
- Review records and documents, for completeness and compliance with global regulations.
- Generate standard operating procedures and/or guidelines to define and improve quality system functions.
- Support and manage document lifecycle the Electronic Document Management System (EDMS).
- Track and trend compliance paperwork (deviations, change controls, etc. both internal and external).
- Oversee training documentation and compliance metrics through use of learning management system (LMS).
- Assist with employee “on-boarding” training on general quality specific procedural requirements.
- Ensure organizational charts are updated on a regular basis.
- Participate in the internal audit program.
- Create and modify user groups, training items, curricula, group trainings and assignments.
- Conduct periodic review and audits of Quality Systems.
- Assist with preparation of QMS metrics.
- Highly motivated individual with excellent time management skills.
- Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
- Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
- Excellent written and oral communication skills.
- Ethical, self-motivated and self-directed.
- Bachelor’s degree with practical experience in a regulated manufacturing environment or equivalent experience
- A minimum of 4 years of relevant experience 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.
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