Descrizione:
Overview
Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. By conducting clinical trials and surveillance, we ensure the safety and efficacy of existing and pipeline products, producing safe, effective, innovative medicine.
Responsibilities
The Clinical Quality Operations Manager (CQOM) is responsible for:
- Leading the strategic implementation of ‘quality by design’ principles in assigned clinical trials.
- Developing risk assessment and categorization tools and quality plans in partnership with the Clinical Trial Team.
- Periodically reviewing therapy‑area level quality plans and risk mitigation approaches, providing feedback to leadership.
- Facilitating and overseeing responses to audit and inspection observations.
- Analyzing data across therapy areas to identify signals and trends and implementing process improvement strategies.
- Staying current on Good Clinical Practice and digital data management technology, maintaining profound knowledge of GCP with respect to digital data management.
- Building effective working relationships with key stakeholders, ensuring role clarity and business effectiveness.
- Ensuring comprehensive oversight of all activities delegated to third parties.
- Maintaining regulatory inspection readiness, preparing for inspections, and managing follow‑up actions.
- Monitoring and communicating regulatory developments within the CQO organization.
- Coordinating cross‑functional teams (Quality & Continuous Improvement, GCTO Country Operations, PV, GRACS, IT, etc.) to support regulatory inspections worldwide.
- Maintaining the global inspection tracking system, auditing findings, responses, and CAPAs.
- Tracking and verifying completion of CAPA and regulatory commitments related to audits and inspections.
- Providing guidance to Clinical Quality Community Managers on country‑level site inspections.
- Contributing to the GCP Quality and Compliance Council and strengthening company programs and strategies to increase inspection readiness.
- Leading, driving, facilitating, and supporting remediation, prevention activities, process improvement, and training as needed.
Qualifications
- B.A./B.S. or M.A./M.S. Degree (or equivalent) in a relevant health care area. Further formal education in quality management or business management is preferred.
- Minimum of 6 years in clinical research, including at least 2 years managing clinical quality systems and regulatory inspections.
- Profound knowledge of clinical development programs, trial processes, quality management systems, and quality control tools.
- Expert knowledge of GCP/ICH and worldwide regulatory authority requirements.
- Demonstrated CAPA management experience.
- Experience with risk management tools and processes within the clinical quality framework.
- Superior oral and written communication skills in an international environment.
- Excellent project management, organizational, teamwork, leadership, conflict resolution, and discretion.
- Ability to lead cross‑functional teams of business professionals within and outside the Research division.
- Ability to act urgently for worldwide health authority inspection matters.
- Analytical, strategic, critical, objective thinking with creativity and innovation.
Required Skills
Adaptability, Clinical Quality Management, Clinical Study Design, Clinical Trials Monitoring, Data Analysis, Emerging Risks, Good Clinical Practice (GCP), Process Improvement Projects, Regulatory Compliance, Regulatory Inspections, Risk Management, Stakeholder Relationship Management, Strategic Thinking, Training and Development.
Preferred Skills
Oncology.
Salary
Salary range: $142,400.00 - $224,100.00. Annual bonus and long‑term incentive may be applicable.
Benefits
We offer a comprehensive package of benefits, including medical, dental, vision, other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, compassionate, and sick days.
Equal Employment Opportunity
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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