Clinical Quality Operations Lead – Inspection Strategy Merck Sharp & Dohme

Merck Sharp & Dohme

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Job type

  • Full-time


126 E. Lincoln Avenue, PO Box 2000, Rahway, NJ 07065-0900, United States of America

Full job description


Join our team as a Clinical Quality Operations Lead – Inspection Strategy and be at the forefront of developing and implementing policies, processes, and procedures related to Health Authority inspections. Your expertise and guidance will ensure the smooth management, training, and support of regulatory Health Authority inspections, solidifying our commitment to quality and compliance.

You will oversee the process for completion of Corrective and Preventative Actions (CAPA), as well as associated regulatory commitments made to Health Authorities. With collaboration with other functions within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported and managed and that QCO are mentored and developed to lead/support regulatory GCP inspections.


In this role you will:

  • Lead Regulatory Compliance: Develop and maintain GCP inspection procedures and guidelines, driving alignment and consistency across our organization. You will serve as the go-to person for ensuring compliance with international standards and monitoring regulatory trends.
  • Inspection Management: Oversee the strategy for global GCP inspections, ensuring all phases of Health Authority inspections are handled professionally. From pre-inspection preparation to tracking submissions and implementing Corrective and Preventative Actions (CAPA), you will be the driving force behind our commitment to regulatory compliance.
  • Proactive Communication: Develop and implement a proactive inspection communication and education strategy. From individual presentations to enterprise-level communication, you will ensure our teams are well-prepared and equipped to excel during inspections.
  • Collaboration and Mentoring: Collaborate with cross-functional teams to support and adequately manage Good Clinical Practice Health Authority inspections. Additionally, mentor and develop staff within QCO, empowering them to lead and support regulatory GCP inspections.
  • Insightful Data Analysis: Analyze inspection data to identify emerging signals, trends, and risks. Leveraging this valuable insight, you will provide feedback to senior management and drive continuous improvement initiatives.
  • Quality Improvement Champion: Act as an expert in international GCP requirements and inspection trends. You will identify inspection risks, lead remediation activities, and contribute to process improvement initiatives, ensuring our global quality strategy is second to none.
  • Regulatory Influence: Maintain an up-to-date knowledge of GCP guidelines and regulations, actively engaging in external GCP working groups to influence the regulatory environment positively.


To be successful in this role you will need:

  • Expertise in Health Authority Inspections and knowledge of GCP guidelines and regulations to ensure that Health Authority inspections are conducted in accordance with these standards.
  • Experience in Inspection Management, overseeing the management, training, and support of regulatory Health Authority inspections.
  • Strong Regulatory Compliance skills and experience in developing and revising policies, standard operating procedures (SOPs), and training materials to ensure compliance with regulatory requirements.
  • Excellent communication and leadership skills to collaborate with various functions within the organization and external stakeholders.
  • A proactive approach to inspection management by developing a communication and education strategy, ensuring cross-functional support for Health Authority inspections, and maintaining a global inspection database/system.


We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.


Job Posting End Date:

23rd May 2024*

  • A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Current Employees apply HERE


Current Contingent Workers apply HERE


Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.


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Job Posting End Date:


  • A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:05/23/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R292455





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Ethan Anderson

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