Jobs at Replimune

Supports the Quality Assurance department in maintaining GMP compliance and the Quality Management System. Responsibilities include batch release, inspection and audit readiness, deviation and CAPA investigations, change control, QMS metrics, vendor qualification, supplier corrective actions, and review or approval of SOPs, validation documents, production records, testing records, and other GMP documentation. The role collaborates with Quality Control, Regulatory, Clinical, Product Development, and external vendors to support compliance and commercial readiness.

Develop and execute strategic account plans for oncology treatment centers and integrated delivery networks. Build relationships with multidisciplinary oncology stakeholders, improve patient access and care coordination, map treatment pathways, support therapy adoption, and collaborate with Medical Affairs, Market Access, Marketing, Patient Services, and Reimbursement teams. Analyze account performance and competitive activity, manage key opinion leader relationships, and use CRM and analytics tools to optimize territory strategy. This is a field-based role requiring extensive travel.

Leads strategic account planning and oncology therapy launch activities for melanoma treatment centers. Builds relationships with multidisciplinary oncology stakeholders, improves patient access and care pathways, analyzes account and market performance, supports disease-state education and product adoption, and collaborates with Medical Affairs, Market Access, Marketing, Patient Services, and Reimbursement teams. This field-based role requires extensive travel and strong pharmaceutical or biotechnology oncology account-management experience.

Develop and execute strategic account plans for oncology treatment centers, build partnerships with multidisciplinary healthcare teams, improve patient access and care pathways, support therapy adoption, analyze account and market performance, and collaborate with Medical Affairs, Market Access, Marketing, Patient Services, and Reimbursement teams. The field-based role requires extensive territory travel and oncology pharmaceutical or biotechnology sales experience.

Drive strategic account plans and oncology therapy adoption across melanoma treatment centers and integrated delivery networks. Build partnerships with multidisciplinary oncology teams, map patient pathways, improve patient access, coordinate cross-functional launch activities, analyze account and market performance, and develop relationships with key opinion leaders. The field-based role requires extensive travel and expertise in pharmaceutical or biotechnology oncology sales, complex healthcare systems, and multidisciplinary care coordination.

Drive strategic account plans and product launch success for an oncology therapy across melanoma treatment centers and integrated delivery networks. Build relationships with multidisciplinary oncology stakeholders, optimize patient access and care pathways, analyze account and market performance, and collaborate with Medical Affairs, Market Access, Marketing, Patient Services, and Reimbursement teams. The role requires extensive travel within an assigned geography and strong oncology account-management expertise.

Provide on-floor quality oversight for Drug Substance, Drug Product, and QC operations to ensure cGMP/GDP compliance. Perform batch record and quality record reviews, walkthroughs, inspections, deviation support, and escalate issues. Support audits and collaborate cross-functionally to maintain an inspection-ready, quality-focused environment.

Execute and improve daily HR operations including ADP data maintenance, payroll for exempt and non-exempt staff, onboarding/offboarding, contractor records, employee file audits, HRIS and LMS data administration, and serve as primary HR contact for employees and internal partners to ensure compliance and support.

Lead development and oversight of quality assurance systems for clinical and post-market pharmacovigilance and medical affairs. Ensure GCP/GVP compliance, inspection readiness, vendor oversight, regulatory interactions, KPI/KQI metrics, training, risk-based quality strategies, and cross-functional process improvement to protect patient safety and data integrity.

Lead development, implementation and maintenance of GxP-compliant quality systems (ICH Q10) including document control, training, change control, deviations, CAPA, metrics and inspection readiness. Manage eDMS (MasterControl), drive continuous improvement, support inspections, and lead the international quality systems team while partnering across functions and sites.

Provide biostatistical leadership for clinical trials including protocol input, SAP and TLF development, database monitoring/lock, efficacy analyses (SAS), CRO oversight, regulatory submission support, and publication/conference contributions.

Lead and oversee aseptic drug product manufacturing at a new cGMP facility, ensuring sterile operations, contamination control, environmental monitoring, batch record management, CAPA/investigation support, equipment maintenance, technology deployment, staff hiring and development, and regulatory interactions to achieve commercial readiness and compliance.

Perform cGMP/GLP QC analytical testing of raw materials, in-process, drug substance and final product per SOPs. Maintain QC systems, review data, support method qualifications, investigations (OOS/OOT), CAPA/change control, equipment validation, sample management, and training. Support audits, regulatory inspections, vendor interactions, and coordination with external testing labs to ensure GMP compliance.

Support and maintain GxP-aligned Quality Systems for multiple sites: manage controlled documents and archival, administer MasterControl and Veeva, handle Jira document requests, create training items, support audits, generate QMS metrics, and drive continuous improvement to ensure cGMP compliance and inspection readiness.

Provide QA oversight for GMP manufacturing and testing, perform batch reviews to support product release, maintain and improve quality systems (change control, deviations, CAPA), lead audits and vendor oversight, ensure compliance with MHRA/EMA/FDA, train staff, and manage QA documentation and metrics.

Lead development, qualification, validation and transfer of analytical methods for drug substance and product under ICH and cGMP. Support release, stability, QC, process development, CMC filings, and coordinate CRO/CMO analytics. Troubleshoot methods, supervise assay staff, and provide cross-functional AD representation and regulatory support.

Support day-to-day Quality Assurance operations within a GMP environment: perform batch reviews, assist QMS activities (change control, deviations, CAPA), review and approve SOPs/validation and testing records, conduct root cause analyses, perform compliance walkarounds, track QMS metrics, manage controlled documentation, and liaise with internal teams and external vendors to ensure regulatory compliance.

Lead revenue accounting and Order-to-Cash implementation for the companys first commercial product. Oversee month-end close, SOX control coordination, gross-to-net and inventory accounting, contract review, Oracle reporting, cross-functional collaboration, and ensure US GAAP compliance.

Perform month-end general ledger tasks including journal entries and reconciliations for cash, investments, prepaids, PP&E, accruals, and AP; record cash transactions and FX rates in Oracle Fusion; manage expense reports via Concur; support SOX controls, SEC reporting schedules, audits, and ad hoc finance projects while collaborating cross-functionally.

Execute packaging and serialization activities for finished drug product in a GMP environment, including equipment setup/operation, line clearance, documentation of batch records, in-process quality checks, visual vial and carton inspection, handling ultra-low temperature materials, and collaborating with Quality and supply chain to ensure compliance and product safety.