Principal Associate II, Quality Assurance

Replimune, Inc.•Framingham, MA

9d•Onsite

About The Position

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients. Join us, as we reshape the future. Job Summary: A self-motivated, detail-oriented Principal II Associate to join the External Quality team. The successful candidate will assist with the implementation of GxP practices, Quality processes with specific emphasis on Final Drug product disposition at Contract Labeling and 3PL facilities, Product Complaint Handling, and CMO labeling review. This role will require adaptability and eagerness to learn about all aspects of the External Quality processes to support relationships with internal stakeholders, contract manufacturing organizations (CMOs), suppliers, 3PL (third party logistics suppliers) and clinical trial sites. The candidate will also interact cross-functionally with internal Quality Assurance, Quality Control, Clinical Operations, and Regulatory teams to ensure compliance to GxP processes and regulations. This position reports to the Vice President Framingham Site Quality and it requires a depth of understanding and significant experience in GxP, quality, communication skills and business acumen to conduct responsibilities autonomously. The Principal II Associate of External Quality is responsible for providing support to ensure continuous supply of investigational medicinal products and / or commercial products with GxP relevant international regulations (e.g., CFR part 210, 211, ICH6, EU, MHRA) and other global requirements. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), or Engineering discipline required. MSc or PhD preferred.
Minimum 6+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or engineering.
A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH guidelines.
Demonstrated knowledge and direct experience with Quality Systems and GxP compliance within a regulated environment.
Experience managing product complaints is preferred.
Experience managing quality events (i.e. Deviations, CAPA).
Experience with Master Control, Veeva or eQMS systems preferred.
Excel, PowerPoint, Word, SmartSheets proficient
Experience revising procedures and documents.
Excellent attention to detail.
Excellent verbal and written communication and presentation skills across all levels.
Prioritize and manage multiple priorities and projects with little assistance.
Familiarity with clinical and commercial supply areas and processes.

Responsibilities

Review packaging master batch records, packaging, labeling, for investigational medicinal product.
Managing Product Complaints for Commercial product
Assist with conducting investigations ensuring effective root cause analysis and assigning of appropriate CAPAs.
Maintain required knowledge of applicable regulations and government, industry, and company standards and their interpretations by participating in industry trainings, workshops, and discussion groups.
Support of other QA projects as needed.
Minimal Travel required - domestic and international.
Represents External Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
Supports continuous improvement by updating policies and procedures as required.
Collaborates cross functionally to support of Replimune’s overall success.
As assigned