Quality Assurance Manager, Finished Goods

Overview

• Manage quality assurance for commercial finished goods and external manufacturing partners in a hybrid work environment.
• Ensure compliance with internal standards and regulatory requirements for global commercial supply operations.
• Collaborate with internal teams and external contract manufacturers to oversee production quality aspects.
• Review and approve manufacturing documentation, including BOMs, MPRs, and product specifications.
• Archive manufacturing partner documentation in the client’s document management system.
• Manage quality records such as deviations, CAPAs, and change controls related to finished goods operations.
• Identify and recommend continuous improvement opportunities to mitigate risks and enhance operations.
• Support business needs by maintaining effective quality assurance processes and practices.

Key Responsibilities & Duties

• Act as QA representative for commercial finished goods and external manufacturing partners.
• Represent Finished Goods Quality Operations in internal and external meetings.
• Oversee quality aspects of specifications, validation, and packaging operations at CMOs.
• Review and approve manufacturing partner and client label and pack documents.
• Ensure proper archival of manufacturing partner documentation in the document management system.
• Manage quality records, including deviations, CAPAs, and serialization excursions.
• Recommend and implement continuous improvement initiatives to support operational effectiveness.
• Train and lead teams in root cause analysis and effective investigation practices.

Job Requirements

• Bachelor’s degree in life sciences, engineering, or related field.
• Minimum of 5 years of experience in pharmaceutical or biopharmaceutical industries.
• Proficiency in finished goods assembly, labeling, and packaging operations.
• Strong organizational, communication, and interpersonal skills.
• Experience managing quality records and ensuring compliance with regulatory standards.
• Ability to recommend and implement continuous improvement initiatives.
• Proven ability to lead and train teams in investigation practices.
• Familiarity with document management systems and quality assurance processes.