Job Description
The schedule for this position is M-F Business hours (full time, on-site)
About This Role
The Sr. Associate III of Quality Engineering and Quality Systems is responsible for understanding quality systems and maintaining oversight of GMP activities while supporting Automation, Engineering, Facilities, Manufacturing, and Quality Assurance/Quality Control stakeholders at the Biogen Research Triangle Park (RTP) Pharma facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement cross functionally and globally. Additionally, the Sr. Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture.
What You'll Do
- Assist in the development and implementation of Global Quality Systems, leading site and global initiatives, provide oversight with respect to the proper administration and adherence to all Biogen policies and procedures as well as regulatory licenses and regulations, and interfacing with key Engineering, Manufacturing, and Quality customers.
- Review of GMP raw data for compliance, review and approval of GMP documentation (including CAPAs, change controls, drawings, exceptions, procedures, records, shutdown documentation, validation protocols, work orders, etc.), and identify gaps in existing quality systems and propose solutions to site management.
- Maintain oversight of quality systems and GMP activities, as well as site performance monitoring systems - such as Quality Council, Site Management Review, Site Governance Boards (e.g., CAPA Review Board, Change Control Review Board, Deviation Review Board)
- Proactive identification and resolution of both technical and compliance issues/gaps. Develop and implement aspects of various Quality Systems/System Improvements.
- Issuance of Batch Production Records, Solution Lot Records, Labels, and Logbooks.
- May support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. In addition, support the manager for activities related to training of employees, as well as compliance with training policies.
- Additional duties as assigned.
Qualifications
Required Skills
- Bachelor's Degree in engineering or related life sciences field
- Minimum 7-10 years of experience working in Quality in a biotech/pharmaceutical GMP environment
- Expertise with Change Control, Exceptions Management, and Record Issuance
- Thorough knowledge of current global Regulatory Quality requirements
- Knowledge of industry practices in Engineering, Quality Control, Quality Systems, and Validation
- Regulatory Agency inspection experience
Preferred Skills
- Knowledge of labeling/packaging operations
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.