Associate Director, Headquarters Clinical Quality ManagementMerck & Co., Inc - Rahway, NJ
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
legacy for over a century
. 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.
It is business critical that Merck receives consistent and accurate high quality data from investigational sites around the globe. Under the guidance of HQ CQM Lead, Director, the HQ CQM, AD will oversee clinical quality management within the Therapeutic Area supporting Clinical Trial Teams (for in or outsourced trials) to proactively embed quality into Merck sponsored trials, ensure adequate vendor oversight for outsourced trials and address any quality issues as needed.
The incumbent will be responsible for the development of Quality Plans to implement Quality by Design within Clinical Development Programs, using a risk based approach and collaborating in implementing, and executing of the Quality Control activities at Headquarters (e.g. through central monitoring) as well as in the GCTO countries (e.g. through targeted QCVs at selected sites).
The incumbent will work with employees from all areas within and outside GCTO and will manage and / or co - lead key initiatives charged with executing the continuous improvement initiatives in Clinical Research.
Provides real - time, proactive advice and guidance on procedures and issues relating to Quality, Compliance and Global Processes related to clinical development program management, clinical trial activities and vendor oversight.
Supports creation of the Quality Plan and performs quality data review for Clinical Development Programs that are prioritized according to the Book of Business and in agreement with CSSM Heads and Clinical Therapeutic Area Heads.
Facilitates appropriate quality issue escalation and resolution in accordance with all applicable change management processes.
Audit and Inspection Support:
Develops and maintains Story Boards for Clinical Development Programs and pivotal clinical trials to implement a risk based mitigation approach in view of inspection readiness.
Supports the Global Inspections Management group, as part of preparation support teams for trial - related sponsor and / or site related inspections.
Supports the development of responses to audits and inspections and ensures appropriate CAPA implementation.
Ensures that all actions and commitments are implemented in a timely manner.
Quality Signal Detection:
Supports Therapeutic Area staff with in depth knowledge of current audit and inspection trends across and within programs.
Develops, implements and analyzes TA specific holistic quality plans (risk based approach) to detect quality signals before they are identified as audit observations and / or inspection findings.
Develops and manages targeted QCVs, including the analysis and development of appropriate action plans in agreement with defined thresholds.
Quality Signal Analysis:
Provides processes, systems and knowledge needed to proactively disseminate known and potential quality issues from local / regional to global perspective.
Supports QCI Management and Therapeutic Area staff by providing an ongoing consolidation and current overview of known issues.
Quality Issue Prevention:
Deploys and maintains global Quality Information management tools (e.g. Story Boards) to track and trend issues as well as manage them through their implementation life - cycle.
Implements a Quality by Design approach from initial Protocol through Clinical Study Report.
Provides input and approves trial specific monitoring plans
Supports qualification and quality management of global vendors.
Education Minimum Requirement:
Bachelor's Degree in relevant Health Care area
A minimum of 5 years of relevant experience in clinical research including direct field monitoring experience or management / oversight of such individuals, with a demonstrated record of accomplishments.
Required Experience and Skills:
Direct experience in quality management, GCP Auditing and GCP Inspections.
Experience with completing risk assessments
Experience delivering effective CAPA management solutions.
Preferred Experience and Skills:
Superior oral and written communication skills in an international environment.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to analyze, interpret, and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
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Clinical Research Generic
Upper Gwynedd, PA, US
Yes, 20 % of the Time
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13 days 6 hours ago
applyAssociate Director, Headquarters Clinical Quality Management Merck & Co., Inc - Rahway, NJ, United States
Merck has a long and rich history of working to improve people's health and well-being. Through the years, our researchers have helped to find new ways to treat and prevent illness - from the discovery of vitamin B1, to the first measles vaccine, to cold remedies and antacids, to the first statins to treat high cholesterol. Our scientists also have helped develop many products to improve animal health, including vaccines and antibiotics. While we are proud of our past, we are enthusiastic about the future of this new company and we are excited to help create a healthier, brighter future for people around the world.
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