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Merck · 20 hours ago

Clinical Systems Quality Manager - Hybrid

Rahway, NJ

Full-time

Hybrid

Senior Level

$115K/yr - $180K/yr

5+ years exp

Merck is a global healthcare company that focuses on research and innovation in the field of clinical trials and pharmacovigilance. The Clinical Systems Quality Manager will ensure that clinical systems comply with regulatory requirements and high-quality standards, overseeing quality and regulatory requirements for IT systems across Global Clinical Development and Global Regulatory Affairs & Clinical Safety.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Computer System ValidationSoftware Development Life CycleQuality ManagementClinical Trial ComplianceRoot Cause AnalysisClinical PracticeProject ManagementAnalytical AbilityCustomer Service OrientationLeadership SkillsCommunication SkillsTeam Collaboration

Required

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

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