• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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
• Direct experience in quality management, Auditing and supporting Inspections
• Experience in Root Cause Analysis, identification and documentation of appropriate corrective and preventive actions
• 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
• 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

Accountability, Accountability, Adaptability, Business-IT Alignment, Clinical Development, Clinical Quality Management, Clinical Research, Clinical Trial Compliance, Clinical Trial Development, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Data Analysis, Dedication to Patient Care, Ethical Standards, Good Clinical Practice (GCP), ICH GCP Guidelines, IT Project Lifecycle, IT Systems Development, Leadership, Leadership Mentoring, Management Process, Pharmaceutical Regulatory Affairs, Quality Assurance Processes, Quality Management {+ 4 more}

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• 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
• More information about benefits is available at https://jobs.Company.com/us/en/compensation-and-benefits

No relocation