GCP Inspection Management Lead Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the guidance of the Head GCP Inspection Management, the Senior GCP Inspection Lead (GIL) will lead the preparation, notification, conduct and follow-up of any Regulatory Health Authority inspections related to clinical studies sponsored by Merck worldwide. He/she will collaborate with and guide employees within Global Clinical Development in order to ensure that Regulatory Health Authority inspections are adequately managed, supported and facilitated. He/she will design and implement processes and activities (e.g. risk assessment/management, coaching/training, mock inspections) in order to ensure that Merck is adequately prepared for any GCP inspection worldwide. He/she may lead pre-approval inspections at Merck company locations globally, and provide support for inspections at clinical investigator sites and vendor locations for NDA/BLA/MAA (or equivalent) submissions.
The Senior GIL will perform QC activities regarding inspection preparation plans prepared by peers and will support other GCP Inspection Leads with establishing a risk-based approach regarding Regulatory Health Authority inspection management (i.e. act as SME function).
The Senior GIL will support the Head of GCP-IM in monitoring and identifying portfolio risks relating to key regulatory submission activities. The Senior GIL will maintain oversight of all potential future inspection activities in their assigned therapy area and will prepare summaries for senior management as required.
The Senior GIL may act as back-up to the Head of GCP-IM in preparing and presenting periodic portfolio risk assessment and inspection analyses/metrics to Senior Management.
CORE Accountabilities and Responsibilities, include but are not limited to:
- Overarching Responsibilities:
- Helps to develop the strategy for and directs the overall management/support for inspections at Merck Headquarters to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection liaison activities during the inspection, development and approval of the inspection response (Inspection Response Document), and implementation of Corrective Action and Preventive Actions (CAPA) Plan) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory responsiveness and compliance.
- Develops in collaboration with Clinical Quality Management (CQM) an inspection preparation plan for programs/trials being submitted to Health Authorities and provides oversight and tracking of all activities.
- Ensures that, as a result of inspection preparation, storyboards are being developed for key processes and activities.
- Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, PV, Regulatory Affairs, IT) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
- In collaboration with the Global Inspection Coordinator and Head, GCP-IM maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
- Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Support/Inquiries to provide real-time, proactive advice and guidance.
- Escalates potential significant inspection findings/compliance risks/impact to Merck Senior Management.
- Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
- Tracks all submissions to Health Authorities to ensure that inspection preparation plans are implemented in a timely manner and informs Head GCP-IM and the CQM organization.
- Performs QC review of inspection preparation plans to ensure quality and consistency across GCP-IM.
- Leads inspections at Merck Headquarters, will be inspector facing and will manage the processes and activities within the inspection’s management team (control room and inspection room).
- Responsible for the identification and impact analysis of changes to GCP regulations globally.
- May act as back-up to Head of GCP-IM for development and presentation of portfolio risks and inspection analyses to Senior Management.
- Responsible for ongoing identification of opportunities to further develop and improve GCP Inspection Management strategy, processes, tools and templates.
- May assist the Head of GCP-IM with the mentoring and ongoing development of other team members.
CAPA Management Support:
- Ensures that all actions and commitments related to inspections are implemented in a timely manner. Tracks all inspection CAPA commitments and checks evidence of completion.
- Ensures repository of evidence is complete for all Regulatory Health Authority inspections.
- Tracks inspection findings to determine any gaps within the Quality Management System and ensures CAPA plans are available to address these in a timely manner.
- Ensures consistency of individual CAPA and commitments across similar inspection findings.
- Provides input into Senior Management Quality and Compliance Council regarding Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
- Assesses and provides input to strengthen company programs/strategies with an aim to increase Inspection Readiness.
- Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
- Contributes to the development and critical review of inspection metrics.
- Works with Portfolio Sourcing and Relationship Management (PSRM) and relevant business areas to ensure vendors used for programmatic outsourced studies are qualified to manage Regulatory Health Authority inspections at investigator sites, and will support inspections as stipulated in the Clinical Quality Agreement.
- Reviews inspection activities and results for developing lessons learned. Ensures lessons learned are presented (train-the-trainer) to relevant stakeholders.
- Bachelor Degree or equivalent in relevant health care area
- Minimum of 10 years of relevant experience in clinical research including at least 5 years of direct experience with managing worldwide Regulatory Health Authority inspections (e.g. FDA, EMA, MHRA)
- Deep profound knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management systems and quality control tools is required.
- Comprehensive knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
- Experience with delivering effective CAPA management solutions.
- Experience with Quality Management Systems and the role of inspections within this quality framework
- Experience conducting sponsor/site audits
- Direct field monitoring experience, with a demonstrated record of accomplishments.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Clinical Research Generic
Job Title:Dir, Clinical Research
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
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