What are the responsibilities and job description for the Senior Manufacturing QA Manager - Biological Operations position at BeiGene?
We are seeking an experienced Senior Manufacturing QA Manager to lead our biological operations team at BeiGene.
As a key member of our Quality Assurance team, you will be responsible for ensuring the successful day-to-day management of QA manufacturing shop floor activities, Batch Release Key processes, and QA objectives, while adhering to regulatory compliance and achieving commercial success.
The ideal candidate will have a strong background in quality assurance and control, with a minimum of 5-10 years of experience in the pharmaceutical or biotechnology industry. They will possess excellent leadership skills, with the ability to motivate and guide a team of direct reports to achieve business objectives.
We offer a competitive salary of $120,000 per year, based on experience, as well as a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and generous paid time off.
Key Responsibilities:
- Develop and implement the Quality Assurance Batch Release strategy to ensure it meets business requirements and customer deliverables
- Act as the site Release Responsible Person, interacting with EU QPs as needed for European batch release
- Support QA shop floor activities with resources as needed
- Implement and monitor all Quality Assurance shop floor and batch systems to ensure compliance with FDA/EU regulation
- Participate in regulatory and customer inspections/audits
- Subject matter expert in GMPs: 21 CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs)
Requirements:
- Bachelor's degree in a related scientific discipline with 7 years of experience or above
- Minimum of 5-10 years experience in biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company
- Strong personal leadership, ability to lead small teams
- Good communicator (written and verbal) and Strategic thinker, highly customer focused
- Strong analytical and problem-solving ability
- Hands-on approach, with a can-do attitude
- Ability to prioritize, demonstrating good time management skills
About BeiGene:
BeiGene is a global biotechnology company dedicated to developing innovative cancer therapies that improve patient outcomes and quality of life. We are committed to delivering high-quality products and services that meet the needs of our customers and stakeholders.
Salary : $120,000
