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. 

 

 

 

**We are looking for someone with strong commercial product complaint experience.

 

Key responsibilities:

• Review packaging master batch records, packaging, labeling, for investigational medicinal product.
• Managing Product Complaints for Commercial product a must have.
• 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.

 

Other Responsibilities:

• As assigned

Education:   

• Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), or Engineering discipline required. MSc or PhD preferred.

Required Experience: 

• 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.

 

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. 

 

 

#LI-onsite

 

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $127,500.00 - $165,000.00. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer. At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing equity grants subject to Board approval. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.