Senior Associate, Plant Quality Assurance

Replimune•Framingham, MA

1d•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. 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. The Senior Associate, Plant Quality Assurance (PQA) reports to the Manager, Plant Quality Assurance and is responsible for providing day-to-day Quality oversight to support Drug Substance, Drug Product, and Quality Control operations in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulatory requirements. This position works closely with Manufacturing, Quality Control, and other cross-functional teams to support compliance initiatives, batch record review, quality record review, and maintenance of a quality-focused culture. The Senior Associate serves as a key quality partner on the manufacturing floor and provides guidance to ensure activities are performed in compliance with established procedures and regulatory expectations. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

BA or BS degree in a scientific discipline or related field, or equivalent combination of education and relevant experience.
3–5+ years of experience in the pharmaceutical, biotechnology, or related regulated industry.
Minimum of 3 years of experience in Quality Assurance, Quality Control, Manufacturing, or a related GMP-regulated function.
Working knowledge of cGMP regulations, GDP requirements, and quality systems.
Ability to manage multiple priorities in a fast-paced manufacturing environment.
Strong written and verbal communication skills.
Experience reviewing GMP documentation and quality records.
Demonstrated ability to work collaboratively across multiple departments.

Nice To Haves

Experience providing quality support within a GMP manufacturing environment preferred.

Responsibilities

Provide on-floor Quality Assurance support during second shift operations to help ensure manufacturing and testing activities are performed in compliance with cGMP requirements and approved procedures.
Perform quality walkthroughs and inspections to promote an inspection-ready environment and identify potential compliance concerns.
Support the review and timely closure of quality records, including deviations, CAPAs, and change controls.
Review production batch records, logbooks, and laboratory documentation for accuracy, completeness, and compliance with established procedures.
Assist in authoring, revising, and reviewing quality system documents, including standard operating procedures, training materials, risk assessments, and validation related documentation.
Provide guidance and support to manufacturing and support personnel regarding cGMP, GDP, and quality system requirements.
Participate in root cause investigations and support development and implementation of corrective and preventative actions.
Escalate quality issues and compliance risks to management as appropriate.
Support training activities related to procedures, cGMP requirements, and quality systems.
Identify, own, and execute continuous improvement initiatives, incorporating cross-functional input and driving projects to timely completion.
Support internal and external audits and regulatory inspections as required.
Contribute to continuous improvement initiatives within the Quality Management System.
Collaborate effectively with cross-functional teams to promote quality and compliance objectives.
Perform other duties as assigned.