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Global Inspection Lead - Remote

Merck • Providence, RI, United States • $200k - $250k / year • 1w ago

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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