iTeos Therapeutics SA
Clinical Quality Sr. Manager - Gosselies (BELGIUM)
iTeos Therapeutics SA, Oklahoma City, Oklahoma, United States,
Clinical Quality Sr. Manager - Gosselies (BELGIUM)
iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UClouvain) in 2011.In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO, raising over $230 million of gross proceeds. In June 2021, the Company entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, the Company’s anti-TIGIT monoclonal antibody. As a well-capitalized biotech company, we are positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our innovative science to improve the lives of patients with cancer.Our values - Data Driven, Ownership, Courage, and Stronger Together - form the foundation of who we are as a company and define who we are at our core.iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for
a Clinical Quality Sr. Manager.ROLE: Clinical Quality Sr. ManagerThe Clinical Quality Manager (CQM) will be responsible for prospective and proactive quality control and oversight/managing/directing of the quality activities related to clinical trials sponsored by iTeos and its associated vendors of clinical trials. The primary responsibilities will be to ensure that clinical processes are conducted in accordance with iTeos Quality Management System and Plan and applicable GCP requirements.The Clinical Quality Manager will report to Sr. Director of Clinical Quality and will support global QMS and clinical studies for all product candidates, with one or more indications, from early clinical development to regulatory approval (Phase 1-3) and beyond.MAIN RESPONSIBILITIESCollaborate with Clinical Operations/Development and all related functional areas to ensure that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and iTeos Policies and Procedures.Interpret and provide key metrics to Clinical Operations/Development Team, Quality Team and cross-functional development team members.Support GCP SOP development and serve as quality operations reviewer. Serve as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams.Execute risk-based methodologies for the planning and execution of clinical protocols.Manage clinical quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with QA audit team and clinical development. Ensure timely implementation and closure of CAPAs.Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Ensure timely review and closure of quality issues.Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.Assist with inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and back room during GCP inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program.Use knowledge of GCP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.Present key issues related to clinical quality to Quality Management.Be a self-starting problem solver who drives results through high compliance and a positive work style.All other responsibilities as assigned.PROFESSIONAL EXPERIENCE/QUALIFICATIONSTo perform this job successfully, an individual must have the following educational degrees and/or experience:Bachelor of Sciences Science, Nursing, or related scientific field, or higher, is required.8+ years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP-related Quality Assurance experience.In Depth knowledge of the applicable global GCP regulations, Good Clinical Practices, ICH Guidelines.Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.Organizational and management skills to communicate to multi-discipline project groups.Ability to speak, present data, and defend approaches in front of audiences and inspectors.Ability to comprehend technical information related to equipment, processes, and regulatory expectations.The ability to think strategically and maintain an attention to detail.The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail are equally important.The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.RECRUITMENT PROCESSPlease send your CV together with an adapted cover letter to the following address: jobs@iteostherapeutics.com. Please mention the reference
CQSM
in the mail object. Your application and related information will strictly confidential.For this open vacancy in US, we closely collaborate with Hobson Prior (Recruitment & Selection company). Your application will be automatically forwarded to them. We, together with Hobson Prior, will keep all your data confidential (GDPR compliant approach).
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iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UClouvain) in 2011.In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO, raising over $230 million of gross proceeds. In June 2021, the Company entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, the Company’s anti-TIGIT monoclonal antibody. As a well-capitalized biotech company, we are positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our innovative science to improve the lives of patients with cancer.Our values - Data Driven, Ownership, Courage, and Stronger Together - form the foundation of who we are as a company and define who we are at our core.iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for
a Clinical Quality Sr. Manager.ROLE: Clinical Quality Sr. ManagerThe Clinical Quality Manager (CQM) will be responsible for prospective and proactive quality control and oversight/managing/directing of the quality activities related to clinical trials sponsored by iTeos and its associated vendors of clinical trials. The primary responsibilities will be to ensure that clinical processes are conducted in accordance with iTeos Quality Management System and Plan and applicable GCP requirements.The Clinical Quality Manager will report to Sr. Director of Clinical Quality and will support global QMS and clinical studies for all product candidates, with one or more indications, from early clinical development to regulatory approval (Phase 1-3) and beyond.MAIN RESPONSIBILITIESCollaborate with Clinical Operations/Development and all related functional areas to ensure that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and iTeos Policies and Procedures.Interpret and provide key metrics to Clinical Operations/Development Team, Quality Team and cross-functional development team members.Support GCP SOP development and serve as quality operations reviewer. Serve as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams.Execute risk-based methodologies for the planning and execution of clinical protocols.Manage clinical quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with QA audit team and clinical development. Ensure timely implementation and closure of CAPAs.Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Ensure timely review and closure of quality issues.Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.Assist with inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and back room during GCP inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program.Use knowledge of GCP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.Present key issues related to clinical quality to Quality Management.Be a self-starting problem solver who drives results through high compliance and a positive work style.All other responsibilities as assigned.PROFESSIONAL EXPERIENCE/QUALIFICATIONSTo perform this job successfully, an individual must have the following educational degrees and/or experience:Bachelor of Sciences Science, Nursing, or related scientific field, or higher, is required.8+ years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP-related Quality Assurance experience.In Depth knowledge of the applicable global GCP regulations, Good Clinical Practices, ICH Guidelines.Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.Organizational and management skills to communicate to multi-discipline project groups.Ability to speak, present data, and defend approaches in front of audiences and inspectors.Ability to comprehend technical information related to equipment, processes, and regulatory expectations.The ability to think strategically and maintain an attention to detail.The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail are equally important.The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.RECRUITMENT PROCESSPlease send your CV together with an adapted cover letter to the following address: jobs@iteostherapeutics.com. Please mention the reference
CQSM
in the mail object. Your application and related information will strictly confidential.For this open vacancy in US, we closely collaborate with Hobson Prior (Recruitment & Selection company). Your application will be automatically forwarded to them. We, together with Hobson Prior, will keep all your data confidential (GDPR compliant approach).
#J-18808-Ljbffr