Job Description
OverviewThe Manager of Clinical Quality Assurance will play an important role in ensuring GCP compliance in support of Iovance’s clinical programs. This position partners with other departments such as Clinical Operations, Clinical Data Management, Regulatory Affairs, Clinical Supply Chain and Logistics, Drug Safety and other teams in developing SOPs, conducting clinical audits and document reviews and supporting regulatory agency inspections.Essential Functions and ResponsibilitiesAssist with the development and management of the clinical QA audit program including audits of investigator sites and contract service providers to ensure GCP compliance.Plan and perform clinical GCP audits and GVP audits; issue audit reports and track responses to closureManage external contract auditors as neededEnsure quality and compliance issues are addressed and CAPAs are tracked to completion while maintaining audit and CAPA logs and associated clinical QA documentation.Review clinical protocols, investigator brochures, reports and other documentation to ensure compliance with regulatory requirements.Develop and maintain Clinical Quality Assurance SOPs; contribute to the development of other related procedures (Clinical, Drug Safety, etc.).Assist with preparation of Quality Agreements as applicableReview and approve clinical documents and regulatory submission documents as needed.Support GCP QA regulatory Health Authority inspections such as the FDA and EMA, etc.Perform internal auditsGenerate quality metrics and advise management, as appropriateParticipate in Quality Management Reviews and represent CQA in project teamsProvide GCP training as neededMust adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethnicsPerform miscellaneous duties as assignedTravelSome travel required (approximately 25%).Required Education, Skills, and KnowledgeBS in life sciences or equivalent experienceSound knowledge and understanding of global GCP regulations and guidance8+ years overall QA or clinical experience with at least 2 years of direct and relevant clinical quality assurance experience (GCP)Knowledge of FDA GCPs, EMA Regulations and ICH guidelinesStrong interpersonal, written and oral communication skillsAbility to manage competing prioritiesProficiency in the use of relevant computer systems including MS officePreferred Education, Skills, and KnowledgeOncology experience is a plusPrior experience with regulatory inspections and inspection readiness is a plusThe physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)Must be able to remain in a stationary position standing or sitting for prolonged periods of timeMust be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objectsMust have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.Must be able to communicate with others to exchange informationMental:Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlinesWork Environment:This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal- opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. 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