Executive Director, Quality Assurance

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. Lead and provide End to End quality strategies for the Therapeutic Disease Area: Primary Care as well as for the Global Safety, Pharmacovigilance and Medical Affairs functions.  Define and execute overall quality assurance activities in collaboration with Oncology, Infectious Disease, Vaccines Therapeutic Disease Area Heads, and also with Safety, Pharmacovigilance and Medical Affairs functional area Heads.  Utilize working knowledge and understanding of clinical programs, safety, pharmacovigilance and medical affairs functions, history, and make certain quality principles are embedded in the design of trials, processes and functions.  Work with Merck Research Laboratories (MRL) to develop and execute through deployment of resources the quality assurance activities as well as the QA audit strategy.  Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions and status of competitor/similar products/projects, disease area and unique needs of Primary Care portfolio, Safety, Pharmacovigilance and Medical Affairs to effectively develop and advance end to end QA strategies. Lead MRL QA in the development of quality risk mitigation strategies for the TA, Safety, Pharmacovigilance and Medical Affairs functions.  Engage in appropriate activities to support product regulatory submissions to health authorities as well as defining and implementing the health authority inspections strategies in support of the submissions.  Responsible for effectively assessing program and process risks, forecasting all audit needs for the TA, Safety, Pharmacovigilance and Medical Affairs functions. Collaborate with QA LT to identify and allocate QA resources.  Provide expertise to MRL QA LT, organization, customers and stakeholders via quality activities as well as auditprocesses, systems and responsibilities.  Maintain knowledge of industry quality trends and actively build quality knowledge and industry networkinternally and externally.  Collaborate on the development and implementation of robust strategic sourcing solutions for the MRL QA global organization in partnership with MRL QA LT.  Advise on the MRL QA vision and strategy and support the execution of activities furthering the vision and strategy.  Lead and manage a global team. Qualifications Must have a Master of Science degree in Biomedical Science (or U.S. equivalent).  Must have 10 years of experience in the role of quality assurance lead.  Must have 5 years with direct clinical trial and/or pharmacovigilance experience.  Must have experience interpreting policies and global regulations and guidelines (e.g.US FDA, EU Directives, ICH, National regulations) to ensure company adherence and compliance.  Must have knowledge and understanding of primary care treatment of patients and clinical trials and experience in quality oversight of Cardiovascular and Metabolic Disease Therapeutic Area trials including clinical sites, vendors, labs and other support functions to clinical research.  Working knowledge and quality oversight experience in Safety, Pharmacovigilance and Medical Affairs disciplines also required.  Must have experience building and managing QA programs and functions.  Travel globally required 30% of the time, as needed.  Experience in working with and directly communicating with senior leaders with proven accountability and demonstrated excellent interpersonal, communication, negotiation, influencing and problem solving capabilities also required.  Will supervise 20 employees. Requisition ID: QUA008103
Salary Range: NA
Minimum Qualification
11 - 15 years

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