reputed company Clinical Quality Operations Manager (Remote) in Nashville, Tennessee

Job Description

It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations reputed company {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities reputed company the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will reputed company headquarters clinical quality operations and support clinical trial teams reputed company the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor reputed company and address any quality issues as needed. The incumbent will be responsible for the development of quality plans to implement quality by design reputed company clinical development programs, using a risk-based approach. The incumbent will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections. Primary Responsibilities: Operational Quality Management

• reputed company Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT).
• Collectively and periodically (e.g. quarterly) reputed company a Therapeutic Area (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.
• Responsible for ensuring comprehensive reputed company of reputed company activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT reputed company 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 reputed company for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).
• Facilitate and reputed company the responses to audit and inspection observations as appropriate. In addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals and trends and will then reputed company and implement appropriate process improvement strategies.
• In collaboration with the CQOL, the CQOM will reputed company reputed company 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 profound understanding of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology reputed company clinical trials).
• Build and reputed company 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.
• 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. Inspection Preparation and Management
• Responsible for maintaining reputed company regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the United States of America Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
• Responsible for maintaining appropriate levels of knowledge and reputed company in order to effectively reputed company and support GCP inspections, worldwide. Under the guidance of the CQO reputed company, the CQOM may be assigned as reputed company of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the CQOM is responsible for monitoring, interpreting and communicating key regulatory developments reputed company CQO.
• Collaborate with other therapeutically reputed company CQOM to provide comprehensive reputed company of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
• Develops, updates, and maintains GCP inspection procedures and guidelines reputed company Global Clinical Trial Operations (GCTO).
• Contributes to the development and/ or revision of our Company policies, SOPs and training materials.
• Develops the strategy for management/support for GCP inspections of our Company products to ensure that reputed company 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.
• Ensures that a cross-functional team (e.g. Quality & reputed company 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 reputed company to support any Regulatory Health Authority inspection, worldwide.
• In collaboration with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks reputed company GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.
• Acts as the subject matter expert and primary reputed company of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
• Escalates potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
• Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team. CAPA Management Support
• Ensures that reputed company actions and commitments reputed company to audits and inspections are implemented in a timely manner. Tracks reputed company inspection CAPA and regulatory commitments and checks evidence of completion.
• Ensures repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for reputed company Regulatory Health Authority inspections.
• Provides guidance and support for CCQMs regarding inspections at a country level sites that require headquarters input. Other Responsibilities
• Provides input into GCP Quality and Compliance Council regarding the Quality Management System (QMS), Risk Assessment Categorization Tool (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. Quality Control Visit (QCV), Headquarters Quality Control Protocol (HQ QCP) with an aim to increase Inspection Readiness.
• Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed. Education:
• Bachelor’s/ Master’s Degree or equivalent in relevant health care area. Further formal education in quality management or business management is desirable. Required Experience and Skills:
• 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.
• Knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
• Expert knowledge of International Council for Harmonization Good Clinical Practice (ICH-GCP) and worldwide Regulatory Health Authority requirements.
• Experience with delivering effective CAPA reputed company.
• Experience with risk management tools and processes reputed company the clinical quality reputed company.
• Superior oral and written communication skills in an international environment.
• Manage and reputed company others, including formal performance management reputed company required.
• Excellent project management and organizational skills.
• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
• reputed company cross-functional teams of business professionals reputed company and reputed company the Research & Development Division.
• Act urgently for worldwide health authority inspection matters.
• Analyze, interpret and solve reputed company problems.
• Think strategically and objectively and with creativity and innovation.
• Proficiently interact with reputed company levels of specialists & management and exert influence to reputed company results.
• Identify and summarize the key issues from audits and inspections and to reputed company and deliver lessons learned. ResearchDivisionGCTO #EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers’ Policy – Job Posting and Employee Placement, reputed company employees subject to this policy are required to have a minimum of twelve (12) months of service in reputed company position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position reputed company the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or reputed company Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-reputed company, will be expected to reputed company not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. reputed company Employees apply HERE ( reputed company Contingent Workers apply HERE ( US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here ( if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. reputed company qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights ( EEOC GINA Supplement​ Pay Transparency Nondiscrimination ( We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is reputed company diverse reputed company come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts ( U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company. 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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. Under reputed company State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: $130,960.00 – $206,200.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here ( . Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation reputed company Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Remote Work Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID: R271234 Apply tot his job

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