Clinical Systems Quality Manager - Hybrid

About the position Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. To ensure we receive high quality data from the investigational sites around the globe, our Clinical Research systems have to be compliant with regulatory requirements and follow our SDLC policy. Clinical Systems Quality Manager will be responsible to ensure our clinical systems are developed, validated and implemented while following high quality standards. Under the guidance of Head BEO and in collaboration with IT PM and Business System Owners the CSQM will oversee the quality and regulatory requirements of IT systems across Global Clinical Development (GCD), Global Regulatory Affairs & Clinical Safety (GRACS). This role is one of three core responsibilities mandated by corporate policy 13.5. This role has approval responsibility for any changes to the GxP systems within above organizations. CSQM SDLC: CORE Accountabilities and Responsibilities Responsible for performing quality activities as it relates to GxP automated and computer systems compliance within GCD & GRACS. Works with IT, Business System Owners and the User Community to provide quality services associated with the validation and compliance of automated computer systems (e.g. Change Control, Doc. Management, etc.). Assist in proper validation strategy, review of project/department deliverables to ensure adherence to our policies and procedures. Act as the quality gate at various project checkpoints. Manage the completion of quality review activities to ensure they are completed in a consistent and timely manner across multiple automated and computer systems. Manage automated and computer system related quality activities (e.g. change control, periodic computer systems review, etc.) providing consistent quality guidance across GCD and GRACS business areas. . Provide communications/presentations on quality topics surrounding computer validation to Sr. Management, provide validation guidance for GCP computer systems, participate in corporate, departmental audits and regulatory inspections, assess and determine corrective action for automated or computer system compliance related issues. CQSM SDLC: OTHER Accountabilities and Responsibilities Communication and Oversight : Collaborate with IT system development teams, Business System Owners, Quality & Continuous Improvement (QCI) staff other GCD & GRACS stakeholders to implement quality management tools and procedures to be used developing IT systems according to SDLC Policy 13.5. Training : Actively collaborate with our Research and Development Division Learning & Development and SDLC Policy Owner to support the development and implementation of SDLC related training Process Improvement : Collaborate with IT, Business System Owners and other stakeholders to improve the processes and increase the efficiency in using IT systems to increase the productivity in Clinical Research Trend Analysis and CAPA : Liaise with Global Clinical Compliance GCC and GCTO CAPA Management to monitor trends from system audit findings and assist in response to audit and inspection findings of GCD and GRACS IT systems

Responsibilities

• Responsible for performing quality activities as it relates to GxP automated and computer systems compliance within GCD & GRACS.
• Works with IT, Business System Owners and the User Community to provide quality services associated with the validation and compliance of automated computer systems (e.g. Change Control, Doc. Management, etc.).
• Assist in proper validation strategy, review of project/department deliverables to ensure adherence to our policies and procedures.
• Act as the quality gate at various project checkpoints.
• Manage the completion of quality review activities to ensure they are completed in a consistent and timely manner across multiple automated and computer systems.
• Manage automated and computer system related quality activities (e.g. change control, periodic computer systems review, etc.) providing consistent quality guidance across GCD and GRACS business areas.
• Provide communications/presentations on quality topics surrounding computer validation to Sr. Management, provide validation guidance for GCP computer systems, participate in corporate, departmental audits and regulatory inspections, assess and determine corrective action for automated or computer system compliance related issues.
• Collaborate with IT system development teams, Business System Owners, Quality & Continuous Improvement (QCI) staff other GCD & GRACS stakeholders to implement quality management tools and procedures to be used developing IT systems according to SDLC Policy 13.5.
• Actively collaborate with our Research and Development Division Learning & Development and SDLC Policy Owner to support the development and implementation of SDLC related training
• Collaborate with IT, Business System Owners and other stakeholders to improve the processes and increase the efficiency in using IT systems to increase the productivity in Clinical Research
• Liaise with Global Clinical Compliance GCC and GCTO CAPA Management to monitor trends from system audit findings and assist in response to audit and inspection findings of GCD and GRACS IT systems

Requirements

• Bachelor's degree in Computer Science, Computer Information Science or related area.
• Five years of end-to-end computer system validation experience required.
• Experience in automated or computerized system compliance, project management principles, systems analysis and systems maintenance/support required.
• Position requires experience with an automated or computerized system Software Development Life Cycle (SDLC) methodology in a regulatory environment.
• Requires experience in reviewing validation deliverables.
• Requires management and leadership skills, analytical ability, good judgment, ability to multi-task
• Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs experience in training user communities preferred.
• Strong verbal & written communication skills
• Excellent teamwork collaboration and leadership skills, including conflict resolution expertise and discretion.
• Ability to proficiently interact with all levels of management and exert influence to achieve results.

Nice-to-haves

• Knowledge and understanding of Clinical Trial processes as well as quality management and control tools is preferred.
• Direct experience in quality management, Auditing and supporting Inspections.
• Experience in Root Cause Analysis, identification and documentation of appropriate corrective and preventive actions.
• Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs experience in training user communities preferred.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

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