Site Investigations Lead, Quality Assurance

This position is a full-time on-site role (M-F business hours)

About This Role

The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations processes to ensure execution of an effective and compliant process with global and site procedures for the Biogen, RTP, Bio facility. The SIL will have leadership experience and capabilities to influence, impact, and collaborate with all levels of the organization to achieve meaningful outcomes. Responsibilities include but are not limited to: providing quality direction to the business to ensure efficient and effective execution of the exceptions processes, support review and approval of deviations, lab investigations, CAPAs, and change controls for compliance to applicable regulatory and corporate guidance documents, support the generation of metrics, develop and perform training methodologies to improve capability and competency of investigators and approvers, identify gaps and improvements in existing Quality systems and propose and implement solutions.

What You’ll Do

• Support and approve RTP Bio site exceptions (deviations, lab exceptions, CAPAs) and change controls 
• Serve as the Investigations Subject Matter Expert, supporting the site globally and participating in internal and external inspections 
• Supports resolution of complex technical and compliance issues/gaps of diverse scope 
• Develop and deliver training methodologies to improve capabilities of investigators and approvers 
• Develop, monitor, and review metrics and action plans for investigations program 
• Implement and facilitate meetings and communications related to the investigations program 
• Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure safety, efficacy and purity of products manufactured by Biogen 
• Additional job duties that may be assigned from time to time 

Required Skills

• Minimum Bachelor's Degree required in Life Sciences or other technical discipline 
• Minimum 10 years’ experience directly related to position responsibilities, working within a quality GMP biotech or biopharma environment 
• Knowledge of relevant FDA/EMA regulations 
• Demonstrated leadership abilities, can lead complex problem-solving initiatives across functions and serve as a decision maker within area of expertise 
• Must be able to deal with ambiguity 
• Advanced knowledge and training in exceptions management and root cause analysis tools 
• Detail oriented aptitude 
• Excellent oral and written communication skills; ability to communicate with all levels of the organization 
• Ability to develop innovative/creative solutions for issues of moderate to challenging complexity 

Preferred Skills

• Knowledge of QC testing, out of specifications, and anomalous results investigations preferred  

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.