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Immunocore · 21 hours ago

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Radnor, PA

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Immunocore is a pioneering, commercial-stage T cell receptor biotechnology company focused on developing transformative medicines. The Clinical Compliance/Inspection Readiness Manager is responsible for managing inspection preparedness and compliance activities within clinical operations, ensuring readiness for audits and regulatory inspections while driving continuous improvement in clinical practices.

BiotechnologyHealth CareMedicalPharmaceutical

Responsibilities

Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization

Lead the development and implementation of processes and tools to support teams and functions in being inspection ready

Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring

Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding

Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities

Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

Generate, analyze and communicate inspection readiness metrics

Drive continuous improvement into inspection readiness and inspection conduct support

Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards

Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization

Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g., completed SOP matrices, CVs, JDs etc.)

Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance

Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure

Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities

Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure, as appropriate

Generate, report, and respond accordingly to compliance/inspection readiness KPIs

Support and prepare internal and external clinical operations teams for audits

Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations

Support and manage in collaboration with Quality Assurance the clinical quality database observations

Identify opportunities and provide leadership in continuous improvement of good clinical practices

Establish and assure adherence to budgets, schedules, work plans, and performance requirements, relative to inspection readiness support and clinical compliance activities

Regularly communicate with senior management or executive levels on matters regarding several functional areas

Qualification

GCP trainingInspection readinessClinical complianceRegulatory requirementsClinical operationsQuality AssuranceClinical auditingMicrosoft OfficeContinuous improvementCommunication skillsTeam collaboration

Required

At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or contract research organization (CRO) with experience in compliance, quality, training or related clinical operations function

Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP

Ensure an enthusiastic and open attitude towards continuous professional development

Experience with performing PAI and Inspection readiness assessments

Experience with making high level presentations, both orally and in writing using organizational skills to complement this

Experience with delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand

Experience with taking responsibility and ownership for entrusted tasks; seeing tasks through to completion and dealing with the consequences of failure or success

Experience with being flexible to new ideas and approaches; changes of plans, objectives and/or priorities

Experience with handling disjointed tasks effectively in a highly collaborative, multi-disciplinary team setting

Experience with being able to work productively with others to achieve tasks while showing consideration for the needs and feelings of others

Experience with accomplishing goals under project timelines

BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)