at Merck in Dover, Delaware, United States
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Individual contributor responsible for ensuring the compliance of External Quality Assurance (EQA) processes against approved quality manual documents and/or ensuring robust business systems in compliance with Company policies. The successful candidate will be part of the EQA Compliance/System team, which will provide Quality oversight of Quality and Business processes with EQA and will also drive and participate in cross functional initiatives to develop and optimize Quality systems and business processes.
This role will be accountable for supporting the development, maintenance, and enhancement of critical processes and systems. The Senior Specialist will also be accountable for compiling, analyzing and reporting of associated metrics, supporting the development and implementation of strategic projects, as well as the development and ongoing monitoring of financial plans and performance.
Requires the individual to ensure Quality Systems and business processes are robust, effective and efficient to comply with required regulations, policies, and guidelines governing the manufacture of materials for the Company, and may also be part of the team providing Quality oversight of internal inspection preparedness and performance of internal audits. The role could require routine interactions with all functions supporting the External Network, including interaction with functions across Company’s global network.
+ Serves as Quality SME for EQA; Maintains and provides expertise on EQA quality and/or business systems, tools, data, and processes on an ongoing basis
+ Ensures that the organization operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign
+ Provides support to the organization to facilitate and implement new quality systems introductions and/or improvements
+ Assists with and/or lead the development, and ongoing execution of the Quality Systems
+ Establishes new or improved processes, tools, systems and drives consistent, standard business processes across EQA
+ Supports the compilation, analysis and reporting of metrics, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements
+ Supports audit/inspection readiness of the organization and participates in regulatory and other quality and compliance report-outs; review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted)
+ Provides project management support of EQA
+ Assists in the preparation and coordination of Quality Senior Management presentations at management conferences, training programs, Quality Council, etc.
+ Operates in a safe and efficient manner and in compliance with the Safety and Health Policy
+ Supports the development, implementation, maintenance, and enhancement of critical processes, systems and master data such as COMET SAP, Supplier Transparency, Remedy, GCM Trackwise, Collaboration sites and IPI
+ Maintains and provides expertise on ExN systems, tools, data, and processes on an ongoing basis, specifically COMET SAP via the use of specific T-Codes in COMET SAP
+ Provide ongoing systems SME support ensuring ExN data and processes run smoothly with no interruption to supply
+ Responsible, as needed, for serving on teams when IT and Business systems representation is needed related to any systems, data, or processes in relevant areas
+ Leads and facilitates the training sessions for EQA
+ At least a bachelor’s degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred)
Experience and Skills
+ Minimum five years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
+ Minimum one year in COMET SAP business workflow via T-Codes and/or reporting
+ Strategic and effective analytical and computer skills, including software packages used in the maintenance and analysis of data
+ Ability to analyze complex business processes, develop and implement solutions, and communicate impact to stakeholders
+ Purposeful and effective interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships
+ Work across boundaries; demonstrated interpersonal, relationship building and leadership skills
+ Effective and strategic communication capabilities both verbal and written
+ Supporting regulatory inspections
+ Conversant with all domestic and foreign regulations and compendia governing plant operations
+ Familiar with batch release process and quality notification process
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, 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 …
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.
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Dover, Delaware 19904