Principal Associate II, Quality Assurance Operations

Responsibilities

Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness; Manage/coordinate internal and external batch release for GMP lots, through batch disposition and subsequent release and issuance of Certificate of Analysis / Conformance; Manage Product Complaints for Commercial Product; Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration, marketing authorization and all other applicable requirements through review of testing records, investigations, non-conformances and out-of-specifications as part of the batch release process; Reviewing packaging master batch records, packaging, labeling for investigational medicinal product; Responsible for final approval and authorization of finished product for shipment and subsequent approval of packaging events; Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance, including a summary of findings for any batch that does not meet the standard requirements for final disposition; 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; Oversee progression of batch related Out of Specification investigations and deviations to ensure timely progression for release; Collect and provide input to and communicate performance metrics and data trends to Management for Batch Release related activities; Lead, mentor and coach quality assurance personnel through development of training to support batch release activities/processes; Support internal/external batch release audits as Subject Matter Expert

Requirements

Bachelor degree in appropriate Science (chemistry, biology, biochemistry, microbiology) required; 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 quality events (i.e. Deviations, CAPA); 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

Nice to have

MSc or PhD preferred; Experience managing product complaints preferred; Experience with Master Control, Veeva or eQMS systems preferred

Benefits

annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical, dental, and vision insurance; 401k match; flexible time off; paid holidays including year-end shutdown