Senior QA Manager

Position Summary

The Sr. QA Manager implements cGMP and regulatory requirements at BSM.  The Sr. QA Manager is responsible for maintaining and improving the Quality Culture at BSM and providing leadership to the rest of the GMP team in this regard.

Duties and Responsibilities

• Develop, implement, manage, audit and maintain quality systems to support clinical and commercial and development activities at BSM
• Oversee material lot release activities including specifications 
• Oversee the Excursions program
• Oversee the Disruption to Controlled Environments (DCE) program 
• Assist with Quality System Events (deviations, OOS, CAPA, Change Control, etc.) and chair MRBs
• Provide oversight of Quality Control Microbiology activities
• Assist with vendor qualification and regulatory audits
• Assist with the internal audit program
• Ensure that cGMP requirements and quality standards are recognized, understood and maintained
• Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines
• Work across all disciplines (e.g. manufacturing, quality control, warehouse and engineering) to ensure that a state of audit readiness is maintained
• Keep abreast of changes to quality regulations and guidelines and advise the management team of any business implications of these changes
• Provide quality guidance to development of analytical methods
• Provide quality guidance to product development projects and programs
• Other duties as assigned

Regulatory Responsibilities  

• Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations
• Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements

Supervisory Responsibilities

• Manage quality activities at BSM  
• Provide leadership to the GMP team related to Quality Culture

Experience

• Five (5) to ten (10) years’ experience working in a cGMP environment
• Five (5) years’ experience in a Quality role 
• Three (3) to five (5) years’ experience supervising individuals in a cGMP environment

Education

• Bachelor’s Degree
• Relevant experience may be substituted for degree

Knowledge, Skills & Abilities

• Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat
• High attention to detail
• Good writing, public speaking and presentation skills
• Must be able to travel approximately 10% of the time

Physical Requirements 

• Ability to sit for prolonged periods of time
• Ability to stand for prolong periods of time as required
• Able to lift up to 10lbs