Senior Manager, Clinical Compliance and Inspection Readiness

Vacancy Name
Senior Manager, Clinical Compliance and Inspection Readiness
Vacancy No
VN909
Employment Type
Full Time
Location of role
Gaithersburg, MD, Radnor, PA
Department
Clinical Operations
Key Responsibilities
The Senior Manager of Clinical Compliance and Inspection Readiness 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 and compliance issues.
Key Responsibilities
Lead global Inspection Readiness efforts for specific programs or trials in preparation or in response to RA activity
Organize mock inspections and gap assessments to identify potential compliance vulnerabilities and implement corrective actions prior to regulatory inspections
Develop and maintain inspection readiness tools, including pre-inspection checklists, document repositories, and response protocols
Lead the overall development and delivery of GCP and Inspection Readiness training for the Clinical organization in collaboration with the Associate Director Clinical Operations and Continuous Improvement
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 assessment of compliance with applicable plans, guidance and procedural documents and regulatory requirements
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) within the Quality Management System or other systems as applicable
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.
Proactively 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
Essential Qualifications
Education, Experience and Knowledge:
At least 10 years of 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 the following skill set:
Performing Inspection readiness assessments
Making high level presentations, both orally and in writing using organizational skills to
complement this
Delivering open and honest constructive (positive and/or 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.
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities.
Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.
Being able to work productively with others to achieve tasks while showing consideration
for the needs and feelings of others.
Accomplishing goals under project timelines.
Education & Qualifications
BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)
10+ years’ experience in related area with some experience in QA/Audit setting preferred
Clinical Operations and/or Inspection Readiness experience preferred
Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)
Some international and local travel maybe required. Approximately up to 20 % travel.
Non-Essential Qualifications
Clinical auditing and relevant clinical operations functions
Compliance and training
US Salary Range
$160,000-$180,000
About The Company
Immunocore (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 industry’s 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.