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Quality Assurance Lead, Biogen RTP Facility
2 months ago
We are seeking a highly skilled Senior Associate III to join our Quality Assurance team at Biogen's Research Triangle Park facility. As a key member of our team, you will be responsible for overseeing strategic, tactical, and operational aspects of Quality Assurance, ensuring compliance with regulatory requirements and site procedures.
Key Responsibilities- Batch Disposition: Ensure product disposition documentation and other supporting documents are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
- Technical Consultation: Serve as a highly skilled technical consultant for quality-related issues and assure compliance with regulatory requirements and site procedures.
- Investigation and Review: Assess criticality of exceptions/investigations for product impact, perform thorough reviews of investigations, and determine potential areas within the process that may have attributed to the exception.
- Quality System Improvement: Review documents for compliance, identify gaps in existing quality systems, propose solutions, and drive cross-functional improvement initiatives.
- Collaboration and Leadership: Collaborate with and/or lead cross-functional teams to execute approved projects aimed at increasing overall quality of business.
- Mentorship and Training: Mentor and train less experienced associates across Quality Assurance functions, serving as a technical subject matter expert (SME) in support of department functions.
- 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, and interpersonal communication skills required to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes, and 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.
- Knowledge of drug substance for small scale, large scale, and cell banking.
