Core accountabilities and responsibilities include:
Overarching Responsibilities on inspections:
- Develops, updates, and maintains GCP inspection procedures and guidelines within GCTO.
- Collaborates with Head of CQO and CQOL-Inspection & Enterprise Management to ensure the ongoing development and mentoring of CQOMs with respect to inspection management capabilities.
- Accountable for driving alignment and ensuring consistency in implementation of inspection management processes across GCTO.
- Contributes to the development and/or revision of our company's policies, SOPs, and training materials.
- Identifies industry best practices and leads knowledge management regarding important regulatory developments.
- Leads/co-leads and acts as advisor/consultant for any of our company's sponsor inspection worldwide (HQ and country office).
- Collaborates within GCTO and our Research & Development Division (e.g., CI, MAP, QA) to analyze inspection data to identify emerging signals, trends, and risks.
- Directs and oversees the overall strategy for management/support of global GCP inspections.
- Accountable for development and implementation of a proactive inspection communication and education strategy across GCD.
- Ensures that a cross-functional Inspection Hypercare Team (IHT) is fully informed and capable of supporting any Health Authority inspection, worldwide.
- Oversees the global inspection database/system that tracks all Health Authority submissions and inspections, worldwide.
- Provides periodic reports/updates to senior management related to regulatory agency inspections.
- Acts as the Quality Management subject matter expert and primary point of contact for all relevant functional areas on Inspection Management.
- Escalates potentially significant inspection issues/observations to our company's Senior Management.
- Oversees the development and maintenance of tools for use in managing regulatory inspections.
- Reviews audit plans/reports for awareness and mitigation of potential inspectional exposure.
CAPA Management Support:
- Ensures that all actions and commitments related to inspections are implemented in a timely manner.
- Maintains documented evidence supporting completion of all regulatory commitments.
Leadership/People Management activities:
- Provides leadership, support, and guidance to CQO colleagues assigned to inspections.
- Works with management, peers, and functional leadership to ensure appropriate resourcing for future inspections.
- In collaboration with the Head, CQO and CQOLs, prepares others to assume new or increased responsibilities regarding regulatory inspections.
Routine quality improvement activities:
- Maintains an in-depth knowledge of clinical development and inspection-related issues.
- Identifies inspection risks that may influence global quality strategy/initiatives.
- Leads and supports remediation activities and process improvement initiatives as needed.
- Liaises with our Research & Development Division QA to monitor trends from audits.
- Participates in and represents our company in external GCP working groups.
- Maintains an expert knowledge of GCP, including current and emerging global guidelines and regulations.
Minimum Qualifications:
- Bachelor’s Degree or equivalent in a relevant health care area.
Required experience and skills:
- Minimum of 12 years of relevant experience in clinical research including at least 8 years of direct experience with managing worldwide Health Authority inspections.
- Deep knowledge and understanding of Clinical Development Programs, Clinical Trial processes, and quality management systems.
- Direct knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
- Experience with delivering effective CAPA management solutions.
- Demonstrated teaching and coaching capabilities, and experience as a mentor.
- Superior oral and written communication skills in an international environment.
- Well versed in risk-based approaches to inspection preparation/management.
- Excellent project management and organizational skills.
- Excellent teamwork and leadership skills, including conflict resolution expertise.
- Ability to lead cross-functional teams of business professionals.
- Able to act urgently for worldwide Health Agency Inspection matters.
- Ability to analyze, interpret, and solve complex problems.
- Ability to think strategically and objectively with creativity and innovation.
- Ability to proficiently interact with all levels of specialists & management.
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