Sr. Manager – Quality Assurance

Sr. Manager – Quality Assurance

Requirements

• Bachelor’s degree in a scientific discipline or equivalent experience
• Minimum of 7 years pharmaceutical industry experience in Quality Assurance or other relevant roles
• Knowledge of applicable GMP regulations (e.g., CFRs, EuraLex and ICH)
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
• Attention to detail and proper use of tools for information processing and electronic systems

Responsibilities

• Management and maintenance of quality system processes such as Document Control, Change Control, Deviations, CAPA, and Effectiveness Checks
• Author, revise and implement QA GMP standard operating procedures (SOPs)
• Develop and deliver training on GMP SOPs and systems
• Timely management of batch record review and release to ensure continuous supply for clinical trials and marketed products
• Assists in the management, maintenance, and evaluation of BBGT’s Quality Management Systems processes for optimization and continuous improvement
• Support computer system validation, including the development and execution of system validation plans and performance qualification testing
• Ability to effectively multi-task to meet deadlines and commitments
• Assist in inspection readiness activities for GMP activities at BBGT
• Other duties as assigned or required

Preferred Qualifications

No preferred qualifications provided.