Key Responsibilities

• Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness. Provide QA input and approvals to assist in and drive projects as needed.
• Perform batch review for GMP lots, in support of Qualified Person release including final Quality Review of associated quality records. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
• Drive improvement 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.
• Possess strong writing skills to utilize best practices in documenting deviations in records and associated reports.
• Collect and report quality metrics supporting Quality Management Review (QMR) deliverables.
• Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, GMP records, Testing Records and other records generated by the site ensuring internal and external standards are met.
• Interface and provide support to internal customers.
• Lead and participate in Risk assessments.
• Conduct trainings as needed (change control, batch release, risk assessment methodology, etc.).
• Conduct routine compliance oversight activities e.g. facility/laboratory walkarounds.
• Take part in Replimune internal and external audit program. Lead and direct audits of GMP materials and service providers.
• Interface with 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.
• Ability to prepare slides and provide training to staff in applicable procedures.
• Prepare and issue controlled logbooks for internal customers.
• Archive and retrieval of documentation.
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Other Responsibilities

• Support Replimune QA activities.
• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but are not limited to standard operating procedures, validation documents, material specifications, etc.
• Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to support Replimune Clinical and Commercial operations.
• Other duties as assigned.
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Educational Requirements

• A minimum of a bachelor’s degree (BSc or equivalent).
• Masters preferred.
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Experience And Skill Requirement

• ≥ 4 years’ experience in relevant Quality Systems, technology and/or supervision in a regulated biotechnology or pharmaceutical industry environment.
• GxP experience, including auditing.
• Knowledge of MHRA, EMA and MHRA guidelines regarding GMPs.
• Excellent verbal and written communication skills to interact with other functions.
• High level of attention to details and excellent time management.
• IT skills – competent in using Microsoft Office.
• An interest in pharmaceutical Quality Assurance.
• A level of flexibility is essential to meet varying workloads.
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