What are the responsibilities and job description for the Senior Associate, Quality Supply position at Replimune, Inc.?
Overview
Summary of job description:
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, 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 Senior 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 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.
Responsibilities
Key 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.
Other Responsibilities:
- As assigned.
Qualifications
Educational requirements:
- Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), or Engineering discipline.
Experience and Skill Requirement:
- 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 and commercial supply areas and processes.
- Minimal travel expected.
Location:
This position is based in our Framingham location and typically has a 5-day on-site expectation.
