Job Title: R&D Quality Lead
Location: Site sites based Redmond, with travel to Seattle site, one or twice per week.
Shift: Days, 9am till 5pm. (some flexibility)
About Us: this is who we are
At Just Evotec Biologic, 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 R&D Quality Lead 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 R&D Quality Lead at Just Evotec Biologic, 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.
The R&D Quality Lead is responsible for contributing to the development, implementation, and maintenance of the Quality Management systems and activities for Just-Evotec Biologics (JEB) Product and Process Development (P&PD). This role ensures all relevant quality and regulatory requirements are met for good clinical practices (GCP), good laboratory practices (GLP), good pharmacovigilance practices (GVP) and clinical site and vendor compliance with GxP regulations issued by FDA, MHRA and other applicable regulatory bodies. The role incumbent utilizes experience and regulatory knowledge to assist with inspection readiness and creation of risk mitigation plans to assure adherence to applicable GxP regulations and guidelines in the conduct of clinical trials, ensuring quality and integrity of generated data, and protection of the rights and welfare of subjects/patients.
What You’ll Do:
Provide quality oversight for data generated by the product and process development (P&PD) function
Partner with senior members of clinical and medical staff to develop plans for quality oversight of GCP and GVP activities
Maintain strong relationships with multiple internal and external team members and cross functional groups
Provide quality oversight to GCP/GLP/GVP vendors through vendor qualification and other appropriate quality oversight mechanisms as applicable
Provide leadership for study team inspection readiness, and support GCP/GLP/GVP regulatory sponsor inspections globally
Oversee/support the development of SOPs for internal GCP/GLP/GVP activities as well as monitoring and ensuring continuous improvement of these procedures/processes
Input into planning of audits of systems and processes needed to support regulatory submissions
Continuously assess compliance status of clinical programs/studies
Perform quality document review and approval as required
Assist with or provide GCP/GLP/GVP training for JEB employees as appropriate
Oversee investigations of GCP/GLP/GVP related quality issues, deviations, and root cause investigations. Collaborate with GCP/GLP/GVP functions to identify, assess, and determine effectiveness of CAPAs and manage and approve completion of CAPAs
Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate
Provide input to and support for Quality Management Review
Travel to JEB local and international sites as required
Who You Are:
Bachelor's degree Life/Health Sciences and/or master's degree; a plus
Minimum 7 years of leadership experience
12 plus years' experience in clinical quality assurance or clinical operations background, in a regulated biotechnology, pharmaceutical or diagnostics industry environment
Knowledge of FDA, EMA and MHRA regulations and guidelines regarding GCP required. GLP and GVP preferred
Knowledge of QMS and CAPA related processes and systems is required
Ability to work across GCP/GLP/GVP functional areas and foster a collaborative culture of quality within the organization
Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors, clinical sites and vendors is strongly desired
Must have applied experience in quality assurance auditing and applicable regulations
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. Site based Redmond, with some travel to Seattle site.
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 success.
A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of Just Evotec Biologic.
Let your curiosity guide your career—#BeCurious and explore the endless possibilities at Just Evotec Biologic!
The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
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.