Clinical Supply QMS Operations and Regulatory Intelligence Lead ( MERCUSR121939ENUS)
The Clinical Supply Quality Management System (QMS) Operations and Regulatory Intelligence Lead reports to the Global Development Quality Compliance and Quality Management System Head and is accountable for oversight of QMS Chapter 1 QMS Operations including the Management and Training programs as well as for GMP Regulatory Intelligence specific to Clinical Supply areas.
The responsibilities of this role include, but are not limited to:
Play a key role in the implementation and long-term maintenance of a new QMS, including Development Quality Standards and Development Global Standard Operating Procedures, for all Clinical Supply sites within our company's Global network.
Act as a cross-functional leader and Clinical Supply subject matter expert to provide oversight for QMS Chapter 1 and its associated subtopics: QMS Structure, QMS Document Management, SOP Management and Development Quality Management System Council as well as QMS Subtopic 3.10 Training and Qualification.
Act as a change agent to stimulate, facilitate and coordinate the adaptation of the QMS redesign contributing to the overall the transformation of our company's business and culture.
Provide oversight for the Development Quality Management System Council (DEV-QMSC) and conversely, provide representation within the Quality Management System Council (QMSC).
Guide the Clinical Supply network on implementation of QMS Directives and QMS Bulletins.
Responsible for oversight of the Electronic Document Management Systems (EDMS) and Training systems utilized within the Clinical Supply network.
Significantly harmonize diverse Clinical Supply site Management and Training practices by developing efficient, yet flexible Global and effectively implement at all sites with Clinical Supply functions.
Identify areas of continuous improvement based on identified trends from regulatory inspections and internal audits, and ensure best practice sharing while driving improvement within the Clinical Supply network.
Champion various compliance initiatives as directed.
Liaise with the Clinical Supply QMS Head and commercial regulatory intelligence personnel, as well as external bodies to set policy for Clinical Supply areas and ensure current GMP clinical supply regulatory requirements are met using common as well as developing industry best practices.
Responsible for the discovery, evaluation and potential implementation of clinical supply specific GMP regulatory requirements within clinical supply areas.
Develop and maintain a network of internal and external linkages, trade groups, contacts, etc. to help stay abreast of current trends in GMP regulations, especially with respect to GMP clinical development areas that manufacture Investigational Medicinal Product (IMP).
Identify Clinical Supply specific requirements and evaluate needs for Implementation at Clinical Supply sites producing IMP.
Help ensure pragmatic, streamlined practices are identified to implement new regulatory requirements that are efficient and allow maximum flexibility as required by Clinical Supply areas.
Develop a sustainable program to provide ongoing maintenance and evaluation of revised regulatory requirements, quality standards and procedures.
Provide significant input to developing a new Clinical Supply continuum for our company that is based on regulatory requirements while allowing for the greatest flexibility to allow for rapid, effective and compliant pharmaceutical development process. Ensure phase appropriate needs are considered to minimize unneeded requirements during especially early development manufacturing.
Help to influence the overall industry for best practices and regulatory needs for clinical supply. Do this through established industry connections and contacts, but also through presentations at appropriate conferences and forums.
Bachelor's degree in an appropriate scientific or engineering field of study is required; an advanced degree is preferred.
Minimum of ten (10) years’ experience in the Pharmaceutical or equivalent industry with at least at least four (4) years of leadership experience and a strong commitment to diversity, inclusion and employee development
At least two (2) years’ experience in a regulatory policy and/or intelligence role is required, including experience driving or influencing company policy or operational changes based on regulatory intelligence.
Strong industry connections, along with experience collating feedback and working with professional organizations to forward industry comments on draft regulations is preferred.
Significant experience in clinical development quality requirements is preferred.
Experience directly related to Quality Assurance or Quality Control is preferred.
Strong understanding of domestic and international cGMPs and how they apply in the development space is essential, including FDA, EMEA, Health Canada, TGA, and PMDA.
Additional critical attributes include: a) strong compliance mindset, b) excellent communication skills, c) ability to work collaboratively in team settings and within matrix organizations to achieve objectives, and d) multiple connections within industry to keep abreast of current regulatory trends.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 …
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.
Invent. Impact. Inspire.
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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We 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.
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Shift:1st - Day
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