With guidance from the Process Quality Lead, contributes to the development of the Process Audit Plan pertaining to quality oversight of critical activities. Communicates the overall quality strategy to research business areas including the identification and assessment of risk as it pertains to ongoing process compliance of operational standards and regulatory requirements. The Process Oversight Model requires transparency and collaboration, frequent consultation with the various research business areas as well as assimilating data on history of issues, current performance, and continuous improvement is needed. In addition, pro-active quality support is required through engagement in Quality-to-Quality meetings, Process Networks and other Operational activities. Suggestions for quality improvement and opportunities to build-in quality upfront, are communicated to the research business areas. A detailed understanding of Process Evaluation and Quality Management Systems is required along with the ability to rapidly assess processes end-to-end for; Process/Procedure Structure & Content, Process Monitoring & Oversight, and Process Execution.
Primary activities include but are not limited to:
Under the guidance of the Process Quality Lead, provide support in the development of the Research & Development Division QA Process Audit Plan pertaining to critical activities using the Process Oversight Model. Engage with the research business areas to ensure that research business areas understand the strategy, and obtain appropriate input to the plan, such as recent process changes and/or improvement activities.
Independently implement the audit plan through execution of audit/assessment processes including the organization of the Audit Team, facilitating the audit preparation and scoping activities, ensuring internal audit conduct, and the communication of any identified risk to our Research & Development Division QA management and appropriate research business areas.
Engage in follow up activities related to audit outcomes including guidance on remediation efforts with research business areas, additional audits, and identification of audit outcome metrics to be reported to the quality management functions.
Monitor process performance through established performance measures and assessment of existing data sources. Identify performance signals to improve the quality and reliability of processes, as well as a direction for potential audit target selection.
Build effective working relationships with key research business areas and Process SMEs. Provide Quality Leadership representation and consultation to research business areas as part of formal Quality-to-Quality meetings, Process Networks and other Operational activities, to identify and implement quality by design (QbD) opportunities.
Evaluate a function’s or organization’s Quality Management System, Knowledge of the end-to-end clinical data work flow of electronic records including data quality control steps is required.
Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures.
Contribute to the ongoing development of our Research & Development Division QA operating standards, work instructions, and training materials to further develop competencies within our Research & Development Division QA Vendor group and any other QA areas assisting in support of the vendor quality program.
BS/BA degree in relevant area with a minimum of eight (8) years of experience in the pharmaceutical industry.
Clinical trial and/or Regulatory activities,
Expertise in GCPs and either; Process Evaluation, Quality Management Systems and/or Problem Identification/Solution Methods.
Fundamental understanding of data and submission work flows, and the technology used in support of.
QA and/or QMS oversight activities and/or Data Management background.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In 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.
If you need an accommodation for the application process please email us at firstname.lastname@example.org