Head, Headquarters Clinical Quality Management 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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
It is business critical that Merck receives consistent and accurate, high-quality data from the investigational sites around the globe. The Head, HQ Clinical Quality Management (CQM) will oversee and ensure appropriate clinical quality management across and within the Therapeutic Areas, supporting Clinical Trial Teams (for insourced or outsourced trials) to proactively embed quality into Merck-sponsored trials, ensure adequate vendor oversight for outsourced trials, and address quality issues as needed.
The incumbent will oversee and be responsible for the development and implementation of Quality Plans to implement quality-by-design within Clinical Development Programs, using a risk-based approach and collaborating in the implementation and execution of the Quality Control activities at Headquarters (e.g., through central monitoring) and in the Global Clinical Trial Operations (GCTO) countries (e.g., through targeted Quality Control Visits at selected investigational 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.
- Quality Management subject matter expert and acts as the primary quality link between Clinical Development Therapeutic Area Heads, GCTO, Quality & Continuous Improvement (QCI), and Merck Research Laboratories (MRL) QA.
- Provides real-time, proactive, strategic 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.
- Oversees and ensures implementation of quality-by-design, development of Quality Plans and quality data review for Clinical Development Programs that are prioritized according to the Book of Business and in agreement with GCTO Clinical Sciences & Study Management (CSSM) Heads and Clinical Development Therapeutic Area Heads.
- Oversees and facilitates appropriate issue escalation and resolution.
Audit and Inspection Support:
- Oversees and ensures the development and maintenance of Story Boards for Clinical Development Programs as a key tool to support inspection readiness.
- Assigns appropriate HQ CQM support for trial-related sponsor and/or site related inspections.
- Oversees the development of HQ CQM-related responses to audits and inspections and ensures adequate Corrective Action & Preventive Action (CAPA) implementation.
- Ensures that all relevant actions and commitments are implemented in a timely manner.
Quality Signal Detection:
- Oversees and ensure the development, implementation, and analysis of TA-specific holistic quality plans (using a risk-based approach) to detect quality signals before they are identified as audit observations and/or inspection findings.
- In close cooperation with Clinical Development Therapeutic Area Heads and their management team, identifies areas of emerging compliance risks and initiates remediation and prevention activities.
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.
- Ensures trending of known quality issues, coordinates global and regional investigations.
Quality Issue Remediation:
- Oversees and ensures that quality/compliance issues are addressed in accordance with all applicable change management processes.
- Manages portfolio of global and regional quality initiatives emanating from both reactive (audit and inspection) and proactive sources.
- Ensures that an adequate process for managing Significant Quality Issues is in place and executed for HQ related quality 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.
- Oversees implementation of a quality-by-design approach from initial Protocol development to Clinical Study reporting.
- Ensures appropriate HQ CQM input and approval of trial-specific monitoring plans.
- Ensures appropriate HQ CQM input and approval of CRO management plans for outsourced trials.
- Supports qualification and quality management of global vendors.
- Manages a team of approximately 4-6 direct reports and an overall staff of approximately 30-35 (directors, associate directors, and contractors) to support the Clinical Development Therapeutic Areas in meeting quality management objectives regarding implementation of quality plans and other quality objectives as agreed upon with therapy area leads.
- Performs hiring, coaching, mentoring, and continuous employee development, including regular performance evaluations.
Head, HQ CQM: OTHER Accountabilities and Responsibilities
- Communication and Oversight: Collaborates with QCI staff, Lead SMEs, and Site Ready & Support staff to create clinical quality management tools and procedures to be used for conducting/managing Clinical Trials at Merck investigative sites worldwide. Collaborates with MRL QA to provide input into the risk based auditing approach and ensure effective and efficient quality management and oversight at the Clinical Trial Team and Clinical Sub-Team levels.
- Training: Actively collaborate with MPI (MRL Polytechnic Institute) and QCI staff for the development and implementation of clinical quality management training programs for GCTO and Clinical Development Therapeutic Area staff.
- Clinical Trial Process Improvement: Collaborates with the QCI Continuous Improvement function and Lead SMEs to initiate global process improvement projects and liaises with Global CQM for the successful execution of these projects.
- Bachelor's degree required; Master’s Degree or advanced degree preferred.
- A minimum of 15 years of relevant experience in clinical research which may include direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
- Deep knowledge and understanding of clinical trial processes as well as quality management and control tools is required.
- Understanding the key risks of compliance being the basis for policies and processes as part of Quality Management Systems.
- Demonstrated experience leading cross-functional teams of business professionals.
- Direct experience in quality management, GCP auditing, and supporting GCP inspections.
- Superior oral and written communication and people management skills in an international environment.
- Ability to think strategically and objectively and with creativity and innovation.
- Experience in delivering effective CAPA management solutions.
- Record of accomplishment of initiating, planning, and delivery of projects and knowledge of project management practices.
- Excellent project management and organizational skills.
- Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
- Ability to analyse, interpret, and solve complex problems.
- Ability to proficiently interact with all levels of management and exert influence to achieve results.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Job: Clinical Research Generic
Job Title:Exec. Dir, Clinical Research
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Clinic, Manager, CAPA, Program Manager, Healthcare, Management, Research