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Related keywords
- Manager Quality Operations
- Clinical Operations Manager
- Quality Operations Manager
- Clinical Quality Program Manager
- Clinical Operations
- Clinical Quality Documentation Manager
- Clinical Qa Specialist Quality Operations
- Clinical Quality Manager
- Clinical Quality Assurance Manager
- Clinical Research Quality Manager
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Clinical Quality Operations Manager
Company | Merck |
Address | Rahway, NJ, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Research Services,Pharmaceutical Manufacturing |
Expires | 2023-07-18 |
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- In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
- Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
- Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
- Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.
- Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).
- In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).
- Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
- Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
- Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
- Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
- Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.
- Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
- Lead and support GCP inspections, worldwide. The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
- Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
- In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.
- Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
- Contribute to the development and/ or revision of our Company policies, SOPs and training materials.
- Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
- Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
- Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Track all inspection CAPA and regulatory commitments and checks evidence of completion.
- Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
- Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.
- Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
- Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
- Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
- Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.
- Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
- Experience with delivering effective CAPA management solutions.
- Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
- Experience with risk management tools and processes within the clinical quality framework.
- Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
- Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
- Ability to manage and develop others, including formal performance management when required.
- Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
- Excellent project management and organizational skills.
- Think strategically and objectively and with creativity and innovation.
- Effectively interact with all levels of specialists & management and exert influence to achieve results.
- Lead cross-functional teams of business professionals within and outside our Research Division.
- Act urgently for worldwide health authority inspection matters.
- Superior oral and written communication skills in an international environment.
- Analyze, interpret and solve complex problems.
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