Director, Quality Technical Services and Compliance

Job Description

About This Role:  

The Director, Quality Technical Services and Compliance is responsible for Quality Engineering, Quality Systems, Inspection Management, and Compliance work for the Research Triangle Park Biologics site. This Director will report to the Quality Site Head, and be part of the local Quality leadership team. This role is responsible for the key functional, tactical, and operational aspects within the Quality Assurance team at Biogen Research Triangle Park facilities.

What You’ll Do:

• Manage the Quality Engineering team through planning and directing QA individuals and stakeholders related to automation, FUME (Facility, Utility, Maintenance, and Engineering), validation, and instrumentation & control activities
• Manage the Quality Systems team through planning and directing QA individuals related to activities, reports, metrics, and projects 
• Oversee the site Inspection Management team ensuring site inspection readiness, proper inspection scheduling, execution, and response management
• Execute site metric generation, analyses, trends, and reporting to site leadership and lead the Site Management Review 
• Provide Site Quality support and actively participate with the global Business Process Owner of Exceptions, CAPA, and Change Control in Corporate Quality 
• Participate effectively for both corporate, global and site cross-functional teams as a subject matter expert representative of Quality Assurance.

Who You Are:

You are a technical leader and team player that enjoys leading their organization through deadline driven initiatives. You are unfazed by the challenges of a manufacturing floor. You can effectively plan, communicate, and advocate for the technical instrumentation needs to create quality products on time.

Qualifications

Required:

• Bachelor’s Degree (BA/BS) from a four-year college or university in Life Sciences, Engineering, or a related field
• Minimum of 12 years of experience in the Pharmaceutical or Biotechnology industry, with at least 3 years supporting specifically biologics manufacturing
• Minimum of 5 years of managing Quality or related technical teams in a highly regulated environment
• Advanced knowledge of quality systems particularly: quality engineering, quality systems, quality control, lot dispositioning, document lifecycle management, change control, and exception management
• Knowledge of FDA/EMEA regulations and compliance 

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.