Clinical Quality Operations Manager - Remote

Job Description

In partnership with the Clinical Quality Operations reputed company (CQOL and Head of CQO, the CQOM is accountable 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's sponsored trials, ensure adequate vendor reputed company and address any quality issues as needed. The incumbent will be accountable 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 accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections. Operational Quality Management: The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. The CQOM will reputed company Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. The CQOMs reputed company a specific therapy area will collectively and periodically (e.g. quarterly) reputed company 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.· The CQOM will 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 partnership with the CQOL, the CQOM will reputed company skillsets 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 knowledge of Good Clinical Practice with respect to digital data management (i.e. use of novel technology reputed company clinical trials). The CQOM will 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 our research division QA and acting as the link between Clinical Development, study teams, global business functions and regional study management. The CQOM, in partnership 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. The CQOM is accountable for ensuring comprehensive reputed company of reputed company activities delegated to third parties. This will include, but not be limited to: Facilitating and monitoring CTT reputed company of vendors Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies). Ensuring that essential elements of the quality management system are in reputed company for studies conducted in partnership with non-commercial organizations (e.g. NGO, government or academic institutions). Inspection Preparation and Management: The CQOM is responsible for maintaining reputed company 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. The CQOM is 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 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 reputed company CQO. Work 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 GCTO. Contributes to the development and/ or revision of Company policies, SOPs and training materials. Develops the strategy for management/support for GCP inspections of 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 dedication to regulatory compliance. Ensures that a cross-functional team (e.g. Quality & reputed company Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, PV, 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 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 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 a Company headquarters input. Other activities: Provides 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. Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed. Education: B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area. Further formal education in quality management or business management is preferred. Prerequisites: Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections. Profound knowledge and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools. Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements. Has delivered effective CAPA reputed company. Has worked with risk management tools and processes reputed company the clinical quality reputed company. Skills: Superior oral and written communication skills in an international environment. Ability to manage and reputed company others, including formal performance management reputed company necessary. Excellent project management and organizational skills. Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. Ability to reputed company cross-functional teams of business professionals reputed company and reputed company our Research division Able to act urgently for worldwide health authority inspection matters. Ability to analyze, interpret and solve reputed company problems. Ability to think strategically and objectively and with creativity and innovation. Ability to proficiently interact with reputed company levels of specialists & management and exert influence to reputed company results. Ability to identify and summarize the key issues from audits and inspections and to reputed company and deliver lessons learned. clinicaltrialjobs EligibleforERP Required Skills: Accountability, Accountability, Adaptability, Clinical Data Management, Clinical Development, Clinical Quality Management, Clinical Research, Clinical Site Management, Clinical Trial Management Processes, Clinical Trials, Conflict Resolution, Decision Making, Good Clinical Practice (GCP), Inspection Readiness, Leadership, Management Process, Mergers and Acquisitions (M&A), Operations Support, Pharmaceutical Management, Quality Management, Regulatory Inspections, Regulatory Submissions, Risk Assessments, Risk Based Monitoring, Risk Consulting {+ 4 more} Preferred Skills: 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. As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills 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, Monday - 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”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee’s position reputed company 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.reputed company.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance 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 Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 12/23/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date. Our company is a global health care leader with a reputed company portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical reputed company, reputed company momentum, and an inspiring mission to reputed company new milestones in global healthcare. Apply tot his job Apply To this Job