Vacancy NameClinical ComplianceInspection Readiness Manager - Clinical OperationsVacancy NoVN514Employment TypeFull TimeLocation of roleConshohocken PA or Gaithersburg MDDepartmentClinical OperationsKey ResponsibilitiesThe Clinical ComplianceInspection Readiness Manager is responsible for the management and execution of activities associated with inspection preparedness inspection support clinical procedural development and maintenance clinical training programs and assessment and investigation of clinical quality compliance issues. This onsite position can be located at either our Gaithersburg MD or Conshohocken PA sites. KEY RESPONSIBILITIES• Lead the development and delivery of GCP and Inspection Readiness training for the Clinical o 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 preparationcollection of all training documents in preparation for internal training file audit e.g. completed SOP matrices CVs JDs etc. • Assist with oversight andor conduct compliance assessments including but not limited to vendorcontractor 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 functions to assess process improvement andor 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 complianceinspection readiness KPIs OTHER DUTIES• 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 Experience & knowledgeEssential• At least 8 years relevant experience in a biotechnologypharmaceutical industry andor 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 the following skill set o Performing PAI and Inspection readiness assessments o Making high level presentations both orally and in writing using organizational skills to complement this o Delivering open and honest constructive positive andor negative feedback pertaining to work in hand oTaking responsibility and ownership for entrusted tasks seeing tasks through to completion and dealing with the consequences of failure or success. o Being flexible to new ideas and approaches changes of plans objectives andor priorities. Handling disjointed tasks effectively. in a highly collaborative multi-disciplinary team setting. o Being able to work productively with others to achieve tasks while showing consideration for the needs and feelings of others. o Accomplishing goals under project timelines. DesirablePrior experience with the following would be an advantage• Clinical auditing and relevant clinical operations functions• Compliance and training Education & qualifications• BA BS. or higher in science related field biological science medical pharmacy or other health related discipline• 8 years experience in related area with some experience in QAAudit setting preferred • Clinical Operations andor Inspection Readiness experience preferred • Demonstrated computer skills proven functional knowledge of Microsoft packages MS Word Excel Power Point Outlook MS Project SharePointSome international and local travel maybe required. Approximately up to 20 travel.About the CompanyImmunocore NASDAQ IMCR is a pioneering commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industrys most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need including oncology infectious diseases and autoimmune diseases. At Immunocore we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science Trust Respect Integrity Diversity and Entrepreneurship STRIDE we create an environment where collaboration thrives ideas flourish and transformative changes happen. STRIDE represents more than just letters it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients lives advancing medicine and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such we are committed to fostering an inclusive workplace where everyone feels valued respected and empowered. We encourage applications from individuals of all backgrounds regardless of race color religion sex sexual orientation gender identity or expression pregnancy age national origin disability status or any other characteristic protected by law.