What are the responsibilities and job description for the Sr. Associate, External Quality position at Replimune, Inc.?
Overview
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:
We are seeking a motivated, detail-oriented Senior Associate to join the Supply Quality team. The successful candidate will assist with the implementation of GxP practices, Quality processes with specific emphasis on CMO labeling review, document control, and procedure revision and new procedure development. This role will require adaptability and eagerness to learn about all aspects of the Supply Quality processes to support relationships with internal stakeholders, contract manufacturing organization (CMO), 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 Director Supply Quality and it requires a depth of understanding and significant experience in GxP, quality, communication skills and business acumen to conduct responsibilities with little oversight. The Senior Associate of Supply Quality is responsible for providing support to ensure continuous supply of investigational medicinal 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.
Responsibilities
- Review packaging master batch records, packaging, labeling, for investigational medicinal 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 Supply Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
- Supports the continuous improvement by updating policies and procedures as required.
- Collaborates cross functionally in support of Replimune’s overall success.
Qualifications
Education:
- Bachelor’s degree in science preferred.
Required Experience:
- Minimum 5 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 with Master Control, Veeva or eQMS systems preferred.
- Excel, PowerPoint, Word 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 supply areas and processes
- Minimal travel expected.
About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
We are an Equal Opportunity Employer.
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