Senior Supervisor, Quality Assurance Drug Product

Job Description

The Quality Assurance SeniorSupervisor 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. The QA Sr. Supervisor’s responsibilities include but are not limited to the direction and development of the Quality Assurance department with regard to personnel and QA functions. Additional responsibilities include evaluation, scheduling, and balancing of departmental workload with respect to assignments/responsibilities/personnel, management of projects, adherence to all regulatory licenses and regulations, interfacing with key Quality and Manufacturing customers.

• Maintain knowledge of relevant FDA/EMA regulations and compliance.
• Advanced understanding of Quality concepts; able to practice and implement them.
• Ability to develop innovative/creative solutions to complex problems.
• Investigative decision making skills.Robust knowledge of the manufacturing process.
• Experienced in supervising people, and influencing others within and outside of the Quality Assurance organization.
• Skilled at multi-tasking, delegation, and decision making. Proficient in quality systems particularly lot dispositioning, document lifecycle management, change control and exception management. Must be able to process large volumes of information, make decisions under pressure

Your are motivated, able to work cross functionally, and work collaboratively. You are able maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. Provides guidance to all departments on quality-related issues.Expected to prioritize problems, escalate issues to Senior Management as required, and resolve issues expeditiously.

Qualifications

• Bachelor of Arts/Science Degree in Life Science or other technical discipline with 8+years experiencein pharmaceutical or biotech manufacturing environment.
• Master of Business Administration (MBA) with 5+years related experiencein pharmaceutical or biotech manufacturing environment.
• Master of Science Degree (MS) 5+years of experience in pharmaceutical or biotech manufacturing environment.
• Minimum 6+ years technical and supervisory experience in a regulated environment.

• ASQ Certification

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects usasa 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.