Quality Assurance Manager

Job Title: Quality Assurance Manager
Location: Massachusetts (Onsite)
Job Type: Full-time

Job Description

We are seeking an experienced Quality Assurance Manager to lead and manage our Quality Assurance (QA) team. The ideal candidate will ensure that all quality processes comply with regulatory standards and align with business objectives. This role involves overseeing the Quality Management System (QMS), maintaining compliance with current Good Manufacturing Practices (cGMP), and fostering continuous quality improvement.

Duties and Responsibilities

• Supervise and mentor the Quality Assurance (QA) team, including responsibilities for recruitment, training, and performance coaching.
• Oversee and manage the Quality Management System (QMS), ensuring adherence to regulatory standards for drug quality, strength, identity, and purity throughout production and storage.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) related to quality assurance activities.
• Design and implement programs to enhance quality standards and ensure compliance with business and regulatory requirements.
• Define and enforce inspection standards within the QA department.
• Conduct and manage internal audits to verify compliance with cGMP requirements.
• Develop and oversee a company-wide cGMP Training Program.
• Lead the Change Control Committee, ensuring proper documentation and approval for facility, equipment, product, and process modifications.
• Review and approve operational procedures related to manufacturing, production, testing, and maintenance, including associated documentation.
• Ensure proper quality controls are in place and successfully executed during manufacturing operations.
• Analyze and address any discrepancies found in production records.
• Serve as the QA department's representative in various organizational meetings.
• Develop, manage, and monitor the department's annual budget.
• Oversee the hiring process and manage personnel changes within the QA department.
• Direct and oversee the daily operations of the QA Department.

Qualifications and Experience

• Education: B.S. in a Science-related field (Chemistry, Biology, Pharmacy) or equivalent.
• Experience: Minimum of 5 years of managerial experience in a QA environment, preferably in the generics pharmaceutical industry.
• Expertise: Extensive knowledge of cGMP requirements and Quality Assurance functions.
• Skills: Strong written and verbal communication skills, problem-solving abilities, and attention to confidentiality.

If you are a highly motivated QA professional with leadership experience and a strong background in cGMP compliance, we encourage you to apply.

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