Senior Specialist, Global Quality Management Systems (GQMS) - Field Based, US

The Quality Specialist QMS, reporting to the Senior Director of Quality Management, will provide support to the Global Quality Systems and Global Supplier Quality Management team by executing assigned day to day activities and supporting continuous improvement activities related to JEB Quality Systems, including but not limited to Deviations/Investigations, CAPA, Change Management, Documents/Records Management and Supplier Quality.

Responsibilities

• Support quality systems continuous improvement activities and ongoing compliance initiatives to promote sustainable compliance.
• Exercise professional written and verbal communication skills in supporting internal customer, supplier, client and team member needs.
• Facilitate the lifecycle of controlled documents in the electronic document management system for global quality systems and global supplier quality documents.
• Review global controlled documents for compliance and adherence to process and system requirements.
• Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish supplier to supplier agreements, and perform general customer inquiries.
• Track and support the initiation, execution, status and documentation of Global Investigations, Global CAPAs and Global Change Controls, Supplier Change Notifications, Supplier Onboarding Requests and Non-Conformance Material Reports.
• Assist in the development of quality system metrics to assess system health and assist in developing and implementing mitigation plans to address any adverse trends observed.
• Support regulatory inspections, internal system audits and client audits.
• Support or process administrative changes to the electronic documentation and quality management systems.
•  Participate in site/cross-functional projects, as requested, and represent global quality systems or global supplier quality.
• Execute supplementary GxP activities in support of departmental operations and/or as requested by management.

Qualifications

• Bachelor's Degree in Biochemistry, Biology, Microbiology, Chemistry, or a Scientific/Engineering degree and 5+ years of relevant quality experience in the biopharmaceutical or medical device industry OR Associate’s degree and 7+ years of relevant quality experience OR High school diploma / GED and at least 9 + years of relevant supplier experience.
• Ability to effectively collaborate and communicate cross-functionally and with external supplier and client personnel.
• Ability to work independently and multi-task in a fast-paced, deadline driven organization.
• Strong organizational skills and attention to detail.
• Knowledge of cGMP regulatory requirements – ICH, FDA, EMA
• Working to advanced use of Office 365 applications, SharePoint and SmartSheet
• Working knowledge of electronic documents and quality management systems (e.g., Veeva, Master Control), LIMS and SAP.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.