Job Description
This position will work from 11 AM to 11 PM on a 2,2,3 rotation schedule
About This Role
The Sr. Supervisor, Quality Assurance is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product (DP) facility. Specifically, this role will have primary oversight of the following activities: (1) Shop floor coordination for the shift personnel ensuring real time batch record review, (2) Respond to operational needs that require QA approval (3) Exception review/approval.
What You'll Do
- Set the direction and drive continuous development of the Quality Assurance department; evaluating, scheduling, and balancing of workload, management of projects, and adherence to all regulatory licenses and regulations.
- Ensure product documentation and other documents supporting batch execution are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
- Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions. Actively monitors the applicable data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency.
- Support activities related to interviewing, hiring and training of employees, compliance with training policies, performance evaluations, and supporting resolution of employee-related issues.
- Assess batch acceptance for clinical and commercial production batches and final QA approval of exceptions.
- Support Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required.
- Recommend changes to existing Quality systems and GMP processes (change control), identify gaps in existing Quality systems, propose solutions to QA management.
- Assist QA Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
Who You Are
You are a passionate Quality Assurance leader that embodies and employs a mindset of being "on the floor" building strong relationships with manufacturing personnel to meet production timelines and drive compliance guidelines.
Qualifications
- Bachelor's Degree in a Life Science, STEM or related discipline.
- Minimum of 5 years of experience related to position responsibilities in pharmaceutical or biotech manufacturing environment.
- Demonstrated leadership capability (either directly or indirectly).
- Understanding of Quality concepts; able to practice and implement them.
- Robust knowledge of the parenteral manufacturing process.
- Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel.
Preferred Skills
- Sterile filling and packaging experience.
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.
