Quality Assurance Manager
Description:
Quality Assurance Manager
RESPONSIBILITIES
Ensuring compliance with all Federal, State & Local regulatory requirements for products manufactured at the New York site.
Act as the Quality Assurance lead and management representative for the site.
Manage and enhance the quality management system at the site.
Provide leadership in quality assurance for various functions including quality systems maintenance, material and product release, supply chain, automation, validation, complaints, deviations, CAPAs, and facility engineering.
Develop and implement quality procedures to support commercial cGMP production.
Supervise quality systems during daily production to maintain high product quality.
Lead internal and external audits, and regulatory inspections at the site.
Maintain and present Key Performance Indicators and Quality Metrics to Operations and Senior Quality Leadership monthly.
Manage quality assurance personnel, including recruitment, training, and development to ensure compliance with cGMP and business objectives.
Oversee vendors and suppliers, including auditing as required.
Represent the site and company at external events, conventions, seminars, and trainings.
QUALIFICATIONS
Minimum 10+ years of experience in the medical devices or biopharmaceutical industries.
Must have 5+ years of quality assurance management/supervisory experience
Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations and guidance, and 21 CFR 210, 211, and 820.
Ability to work with a multidisciplinary team and establish working relationships both internally and externally.
Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
Experience in hosting regulatory audits/inspections is preferred.
Ability to read, understand, and write highly technical material.
Proficient in reading, writing, and communicating in the English language.
EDUCATION
Bachelor’s degree in life sciences or related field
Advanced degree is a plus