Senior Associate, Quality Assurance

Replimune-2; Framingham (MA); On-site; USD 106,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Holidays including year-end shutdown

Job summary

Replimune Group, Inc. in Massachusetts is seeking a Quality Assurance professional to support GMP compliance, batch release, and QA operations across departments.

You will partner with Regulatory, Clinical, and Manufacturing to ensure readiness for inspections, maintain the QMS, and drive continuous improvement through CAPA, change control, and document reviews. 3–5 years biotech/pharma QA experience required.

Qualifications

• A minimum of a formal degree; Associates plus applicable work experience may be considered.
• 3-5 years of quality experience in biotech or pharmaceutical industry.
• High level of attention to details and excellent time management.
• A very organised and methodical approach to tasks.
• Strong written and verbal communication skills to interact with other functions.
• IT skills – competent in using Microsoft Office.
• A level of flexibility is essential to meet varying workloads.

Responsibilities

• Provide supporting day-to-day operation of the Quality Assurance department to ensure the implementation and maintenance of Quality Management System (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
• Aid in preparation for inspection readiness and participate actively during inspections and audits.
• Perform batch release for GMP lots, including final Quality Review of associated quality records to ensure closure, preparation of associated batch release documentation to ensure completeness and accuracy in accordance with procedure. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
• Support the oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
• Assist in tracking and populating QMS metrics related to change controls, CAPAs and deviations.
• Conduct / participate in the Change Control Review Board
• Support vendor qualification process, issuance of vendor questionnaire and authoring of vendor quality technical agreements.
• Support supplier corrective action notification and request, vendor notification systems, when applicable.
• Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, Production Records, or GMP records, Testing Records and Engineering Drawings, ensuring internal and external standards are met.
• Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.

Skills

Quality focus

Attention to detail

Time management

Organized

Communication skills

Flexibility

Education

Formal degree

Tools

Microsoft Office

Job description

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.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.

Key responsibilities

• Provide supporting day-to-day operation of the Quality Assurance department to ensure the implementation and maintenance of Quality Management System (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.

• Aid in preparation for inspection readiness and participate actively during inspections and audits.

• Perform batch release for GMP lots, including final Quality Review of associated quality records to ensure closure, preparation of associated batch release documentation to ensure completeness and accuracy in accordance with procedure. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.

• Support the oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.

• Assist in tracking and populating QMS metrics related to change controls, CAPAs and deviations.

• Conduct / participate in the Change Control Review Board

• Support vendor qualification process, issuance of vendor questionnaire and authoring of vendor quality technical agreements.

• Support supplier corrective action notification and request, vendor notification systems, when applicable.

• Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, Production Records, or GMP records, Testing Records and Engineering Drawings, ensuring internal and external standards are met.

• Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.

Other responsibilities

• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.

• Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure commercial readiness for licensure

Educational requirements

• A minimum of a formal degree; Associates plus applicable work experience may be considered.

Experience and skill requirement

• 3-5 years of quality experience in biotech or pharmaceutical industry.

• High level of attention to details and excellent time management.

• A very organised and methodical approach to tasks.

• Strong written and verbal communication skills to interact with other functions.

• IT skills – competent in using Microsoft Office.

• A level of flexibility is essential to meet varying workloads.

Salary Range

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 $106,000 - $137,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected 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 performance-based equity. 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.

• medical
• dental
• vision insurance
• 401k match
• flexible time off
• a number of paid holidays including year-end shutdown

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.