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
- Able to lift up to 10lbs
