What are the responsibilities and job description for the Quality Systems Manager position at BERKSHIRE STERILE MANUFACTURING LLC?
Position Summary
The Quality Systems Manager is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements at Sharp Sterile Manufacturing (SSM). This role oversees the development, implementation, and continuous improvement of quality systems to support a strong compliance culture. The Quality Systems Manager provides leadership and guidance to the team, fostering a proactive quality mindset across the organization.
Duties and Responsibilities
Manage and maintain quality systems to support clinical and commercial and development activities at SSM
Oversee the Document Control and Quality Systems functions.
Oversee the internal audit program
Oversee the SSM Client Audit Program
Provide quality metrics to Senior QA Management.
Assist with Quality System Events (deviations, OOS, CAPA, Change Control, etc.) and chair MRBs
Assist with vendor qualification and regulatory audits
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
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