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

Job Title: Senior Specialist, Global Quality Management Systems (GQMS)

Location: Field Based, US, located near to Redmond, WA                                                       

Department: Quality

Reports To: Senior Director Global Quality Management Systems
 

About Us: this is who we are

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper?   #BeCUREious with us and see where your curiosity can take you!

The Role: Your challenge …in our journey

We’re looking for a passionate and curious Senior Specialist, Global Quality Management Systems (GQMS) to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Senior Specialist, Global Quality Management Systems (GQMS) at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

What You’ll Do:

• 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.

Who You Are:

• 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.

• Knowledge of cGMP regulatory requirements – ICH, FDA, EMA

• Advanced level on Office 365 applications, SharePoint and SmartSheet

• Working knowledge of electronic documents and quality management systems (e.g., Veeva, Master Control), LIMS and SAP.

Why Join Us:

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life, whether that means working remotely or choosing a hybrid model.

• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.

• Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to s