Senior Specialist, Quality Management Systems and Compliance

at Merck in Millsboro, Delaware, United States

Job Description

Job Description

The Senior Specialist, Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems and Compliance and leads global quality support to all internal Animal Health sites, Animal Health External Manufacturing groups and associated functional areas related to the Product Quality Complaint (PQC) system. They also support the Management Notification, Fact Finding, Recall, and Health Authority Notification processes, and participate in additional Quality Systems improvement projects and compliance initiatives.

Primary Activities Include (But are not limited to):

+ Support Global Quality and local country PQC team colleagues with all aspects of the Animal Health Product Quality Complaint (PQC) business process including use and administration of associated IT systems.

+ Conduct training on Animal Health PQC case handling, Quality investigations, and PQC IT system use.

+ Perform PQC case entry for selected markets, weekly review of new case entry, trending of global PQC data, and generation of related metrics reports.

+ Function as the Global System Owner for PQCs. Leads the quarterly PQC Community of Practice (CoP) meetings including the development and delivery of presentation materials, and the organization and planning of all CoP activities.

+ Compile, review and submit PQC reports and provide PQC data /line listings to US Regulatory Affairs for inclusion in Drug Experience Reports to be submitted to regulatory authorities including the US FDA.

+ Support global manufacturing site and local country PQC teams during internal audits and external regulatory inspections including the development of responses and implementation of corrective and preventative actions.

+ Develop and issue Animal Health Quality Actions to all sites and functional areas based on issues originating from a variety of sources including Human Health Quality Bulletins/Directives as applicable.

+ Collaborate with global Animal Health sites and functional areas to implement changes required by Quality Actions and to ensure all related tasks are completed in a timely manner.

+ Support the Management Notification, Fact Finding Meeting, Product Recall and Health Authority Notification processes.

+ Support monthly Quality Review Committee (QRC) meetings and present on topics concerning PQCs, Quality Actions and other Quality Systems Improvement Projects as required.

+ Participate in Quality System Improvement Projects and other Quality compliance initiatives to identify emerging trends and implement system improvements to ensure global Animal Health Quality Systems remain compliant and robust.

+ Pursue continuous improvement in Global Quality business systems, Animal Health Quality Manual SOPs, and associated IT systems related to PQCs, Quality Actions and other quality systems as needed.

Minimum Education Requirements

+ Bachelor of Science (BS) degree in Science, Engineering, or related area of study with five (5) years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements.

Required Experience and Skills:

+ Strong understanding of cGMPs, Quality Management Systems (QMS) and related Health Authority regulations (FDA, EU, and/or USDA).

+ Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

+ Communicates in English, both verbally and in writing.

+ Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

+ Strong and effective compliance and continuous improvement mindset

+ Computer and Information Technology skills

Preferred Experience and Skills:

+ BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred.

+ Previous experience supporting PQC management and regulatory inspections.

+ Strong project management skills

+ Experience working with PV Works, Reliance, MEDS



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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, We

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Job Posting: JC255451162

Posted On: Feb 17, 2024

Updated On: Feb 25, 2024

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