Job Description
Core accountabilities and responsibilities include:
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 regarding 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 and provides feedback to management as appropriate.
Directs and oversees the overall strategy for management/support of global GCP inspections to ensure that all phases of Health Authority/Regulatory inspections (i.e., notification, pre-inspection preparation activities, inspection liaison activities during the inspection, development and approval of the inspection response, tracking of submissions to the Health Authorities, and implementation of CAPA Plan) are handled consistently, professionally, and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.
Accountable for the development and implementation of a proactive inspection communication and education strategy across GCD. This may include, but not be limited to, individual presentations, development of educational programs, facilitating our Research & Development Division course development, enterprise-level communication strategies, etc.
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 as directed by the CQOL- Inspection & Enterprise 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.
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 by providing learning and development opportunities.
Routine quality improvement activities:
Maintains an in-depth knowledge of clinical development and inspection-related issues and acts as an expert on international GCP requirements/inspection trends and developments.
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 and may contribute to responses to audit observations regarding GCTO global processes.
Participates in and represents our company in external GCP working groups.
Maintains expert knowledge of GCP, including current and emerging global guidelines and regulations, and engages in appropriate activities to influence the regulatory environment.
Minimum education required:
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 (e.g. FDA, EMA, MHRA, ANVISA, etc.), conducting both sponsor as well as site audits, direct field monitoring experience, with a demonstrated record of accomplishments.
Deep knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management systems and quality control tools is required.
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 and discretion.
Ability to lead cross-functional teams of business professionals within and outside of our Research & Development Division.
Able to act urgently for worldwide Health Agency Inspection matters.
Ability to analyze, interpret and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
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