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 Software Development Life Cycle (SDLC) policy. Clinical Systems Quality Manager (CSQM) will be responsible to ensure our clinical systems are developed, validated and implemented while following high quality standards.
Under the guidance of Head Business Enablement Organization 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. 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.
- Conduct vendor qualifications as a subject matter expert for eRecords & Technology to ensure that our business vendors are validating their computer systems in accordance with policies and procedures that are compliant with the expectations of global Health Authorities.
- Provide communications/presentations on quality topics surrounding computer validation to Sr. Management, provide validation guidance for GLP, GCP, GMP automated or computer systems, participate in corporate, departmental audits and regulatory inspections, assess and determine corrective action for automated or computer system compliance related issues.
- 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.
- Training: Actively collaborate with Company Research 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
Bachelor's degree in Computer Science, Computer Information Science or related area
- Ten years of overall automated or computer system implementation/validation experience and at least five years of experience in automated or computer system compliance, project management, systems analysis and systems maintenance/support
- Position requires experience with an automated or computer system Software Development Life Cycle (SDLC) methodology in a regulatory environment
- Requires experience in reviewing validation deliverables
- Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
- Direct experience in quality management, Auditing and supporting Inspections
- Experience delivering effective CAPA management solutions
- 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
- Requires experience in training user communities.
- Strong verbal & written communication skills
- Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
- Ability to proficiently interact with all levels of management and exert influence to achieve results.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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