Location: Durham,NC, USA
Company DescriptionJob Description
About This Role
The Senior Associate III is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The Associate has an advanced understanding of Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. This individual provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation and other supporting departments. The Senior Associate III for QA disposition serves as a designee to approve Certificate of Conformance and perform batch disposition. At the RTP Bio site, this individual serves as sub-process owner of drug substance disposition procedures. This is a full time, onsite position.
What You'll Do
* Ensures product disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution. Coordinates batch disposition cross-functionally
* Serves as a highly skilled technical consultant for quality related issues and assuring compliance with regulatory requirements and site procedures
* Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of investigations and determines potential areas within the process that may have attributed to the exception
* Reviews documents for compliance and identifies gaps in existing quality systems, proposes solutions and drives cross-functional improvement initiatives
* Collaborates with and/or leads cross-functional teams to execute approved projects aimed at increasing overall quality of business
* Mentors and trains less experienced associates across Quality Assurance functions. Serves as technical subject matter expert (SME) in support of department functions
* Additional duties as assigned
Who You Are
You are a highly collaborative project-oriented individual. You are meticulous and methodical in your work.
Qualifications
* Bachelor's Degree in Life Science or other technical discipline
* Minimum 7 years directly related to position responsibilities; or Master of Business Administration or Master of Science Degree (MBA/MS) with 5+ years related experience
* Expertise in batch disposition of drug substance, including interpretation of specifications for various markets, in a cGMP environment
* Excellent written, verbal & interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross functionally to drive collaboration, processes & decisions
* Knowledge of relevant FDA/EMA regulations and compliance
* Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel
* Ability to plan, schedule and arrange own activities when accomplishing objectives in an ambiguous environment
Preferred Skills
* Knowledge of drug substance for small scale, large scale, and cell banking
Additional Information
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.