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
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