Clinical Quality Operations Manager

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Perform clinical quality oversight activities within designated clinical trials

• Deliver proactive quality management, risk-based oversight, and management of clinical trial inspections

• Assist Trial Teams in integrating quality into sponsored trials and carrying out quality reviews

• Ensure effective oversight of service providers and address critical quality issues

• Serve as a Process Subject Matter Expert regarding quality processes, standards, and regulatory requirements

• Detect, investigate, escalate, and resolve quality issues at the study level, including Significant Quality Issues and Serious Breaches

• Lead Inspection Hypercare Teams to uphold continuous inspection readiness

• Provide operational oversight during sponsor inspections and function as Control Room Lead or Support

• Act as Inspection Lead for site inspections and conduct pre-inspection visits

• Draft inspection communications, including daily summaries, outcomes, and issue escalations

• Coordinate responses to inspections, root cause analyses, CAPA, regulatory commitments, and documentation

• Assist with Quality Assurance audits before, during, and after the audit process

• Collaborate with the Clinical Quality Risk Manager to implement quality risk management

• Act as the primary clinical quality contact for assigned key service providers

• Develop and manage clinical quality agreements with service providers

• Support quality-related activities in mergers and acquisitions

• Contribute to CQO infrastructure, process innovation, and special projects

• Utilize AI-driven methods and data analytics to enhance efficiency and decision-making

⛳️ Requirements

• Bachelor’s or Master’s Degree or equivalent in a healthcare or scientific field

• At least 8 years of pertinent experience in the pharmaceutical industry and/or clinical research

• Strong knowledge of quality management and clinical trial operations

• In-depth understanding of Quality Management Systems (QMS), ICH GCP guidelines, and global Regulatory Health Authority requirements

• Advanced experience in independent root cause analysis (RCA), CAPA development, effectiveness management, and oversight of service provider quality

• Excellent oral and written communication skills in an international, matrixed environment

• Exceptional project management and organizational abilities

• Capable of leading cross-functional teams comprising business and clinical professionals

• Ability to act promptly and decisively on global health authority inspection matters

• Skilled in analyzing, interpreting, and resolving complex quality and compliance issues

• Strategic and objective thinker with digital proficiency, including familiarity with AI and machine learning tools

• Expertise in CAPA Management

• Knowledgeable in Clinical Quality Management

• Proficient in Data Analysis

• Familiar with Good Clinical Practice (GCP)

• Experience in Process Improvements

• Strong Project Management skills

• Understanding of Regulatory Compliance

• Knowledge of Regulatory Inspections

• Competence in Risk Management

• Ability in Root Cause Identification

• Capacity for Strategic Thinking

• Initiative in Taking Action

• Eligibility for residency in the US and Puerto Rico

🏝️ Benefits

• Annual bonus and long-term incentive opportunities, if applicable

• Healthcare benefits including medical, dental, vision for both employee and family

• Retirement benefits such as 401(k)

• Paid holidays

• Vacation days

• Compassionate and sick leave

• Flexible remote work options

• 25% travel allowance/requirement