Head, Global Clinical Quality Management

14 Jun 2024

Vacancy expired!

Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.It is critical that, for all Company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained.Quality and Continuous Improvement (QCI) establishes and maintains a robust clinical Quality Management System (cQMS) by setting quality standards. QCI ensures that performance of quality standards is measured and improved through a system that encompasses functions at the country, regional and global level. QCI ensures a standardized approach for Clinical Quality Management (CQM) and Continuous Improvement activities worldwide. The Head GCQM position has a significant impact in achieving this objective.Under the guidance of the Head, Quality & Continuous Improvement (Head QCI), the Head GCQM oversees all CQM activities in the regions through a global network of quality experts providing standardized support across all countries for audits and inspections, quality control activities, local / regional process management, quality and compliance issue management, training, and local supplier qualification.The Head GCQM closely collaborates with the Global Head Regional Operations & Monitoring Excellence (Head ROME), the Regional Research Directors (RRDs), other global and regional roles as well as other stakeholders within and outside of GCTO/QCI.In addition, and in close collaboration with applicable stakeholders, the Head GCQM is responsible to oversee the development, global implementation, and continuous improvement of CQM processes and tools.As needed, and upon the request of the Head QCI, the Head GCQM supports global activities/ key initiatives.Specific responsibilities include, but are not limited to:Regulations & ProcessesEnsures timely implementation of new/revised global/regional procedures in the regions.

Ensures proper management of Subject Matter Experts (SME) networks in the regions.

Ensures development and maintenance of local / regional Standard Operating Procedures (SOPs).

Identifies global process gaps / opportunities for process improvement including proper escalation to Head QCI, Global Process Owners and/or other stakeholders.

Supports global process design / improvement activities.

Supports other global activities / key initiatives.

TrainingServes as the GCQM point of contact for Research and Development Division's Learning & Development.

In close collaboration with the Head ROME and RRDs, identifies training needs and initiates/delivers/supports global/regional trainings.

Quality Control (QC) ActivitiesEnsures proper execution of In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs) and any other applicable QC activities in the regions.

Based on the analysis of global / regional QC data, and in close collaboration with applicable stakeholders, supports root-cause-analysis and develop/implement action plan for global / regional trends (if applicable).

Ensures timely completion of Clinical Supplies GCP Investigations.

Audits & InspectionsOversees audits and inspections in the regions.

Ensures proper root-cause-analysis and timely development of responses to audit and inspection reports (Corrective & Preventive Actions / CAPAs).

Ensures timely completion of CAPA commitments including filing of evidence.

Serves as the GCQM point of contact for Research and Development Division's Quality Assurance.

Quality/ Compliance Issue EscalationEnsure communication/escalation of quality/compliance/privacy issues (incl. any potential trends) to Head ROME/RRDs/other applicable stakeholders, as appropriate.

Supports investigation of quality/compliance/privacy issues, as needed.

Attends Quality & Compliance Council meetings and support any associated activities, as applicable.

Supplier Qualification & OversightEnsures GCQM staff is leading and/or supporting local/regional supplier qualifications as well as supplier oversight activities, as needed.

Education:Required: Bachelor's Degree

Preferred: Master’s Degree or equivalent in relevant health care area

ExperienceMinimum 15 years of relevant experience in clinical research including site monitoring / country operations experience, and/or oversight of individuals in these roles, with a demonstrated record of accomplishments.

Strong expertise in Clinical Quality Management (incl. Quality Control Activities and Process Management & Improvement), with a demonstrated record of accomplishments.

Deep knowledge and understanding of Clinical Trial Processes, GCP and other regulations.

Strong expertise in project management practices and solid track record of planning, initiating and delivery of projects including demonstrated experience in leading cross-functional teams.

Positive proven success in managing an organization and people management expertise including allocation of resources, headcount, budget, and travel.

SkillsLeadership skills that enable and drive alignment with the goals and mission of Research and Development and GCTO. To achieve results, this requires ability to proficiently interact with all levels of management and collaborate with different stakeholders in a matrix organization.

Strong leadership that will attract, motivate, inspire, develop, and retain talented staff.

Superior verbal and written communication skills (proficiency in written and spoken English) in an international, mainly remote environment.

Excellent project management, organizational, prioritization and teamwork skills including solving conflict and discretion.

Ability to analyze, interpret, and solve complex problems (incl. root cause analysis).

Ability to think strategically and objectively and with creativity and innovation.

HeadcountPosition manages 8 direct reports (Regional Directors, Clinical Quality Management / RCQMs) overseeing a team of 130 Country Clinical Quality Managers / CCQMs (Company employees as well as contractor resources).Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.Who we are …We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for …Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA Supplement​OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe 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.Search Firm Representatives Please Read CarefullyMerck & 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.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:Remote WorkShift:Not IndicatedValid Driving License:YesHazardous Material(s):Number of Openings:1Requisition ID: R186062

Full-time
  • ID: #42988799
  • State: South Dakota Pierre 57501 Pierre USA
  • City: Pierre
  • Salary: USD TBD TBD
  • Showed: 2022-06-14
  • Deadline: 2022-08-13
  • Category: Et cetera