Quality Assurance Manager

Meet Life Sciences; Cambridge (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading life sciences company in Cambridge is seeking a QA Manager to oversee quality assurance activities for commercial finished goods and manufacturing partners. You will act as a QA representative, ensuring compliance with regulatory standards in assembly, labeling, and packaging. The ideal candidate has a Bachelor's degree in life sciences or engineering and at least 5 years of relevant experience. This position plays a crucial role in maintaining quality records and supporting business needs.

Qualifications

• Minimum of 5 years of experience within the pharmaceutical or biopharmaceutical industry.
• Hands-on experience with finished goods assembly, labeling, and packaging at external manufacturing sites.
• Experience leading or supporting root cause analysis, investigations, and effective corrective actions.

Responsibilities

• Act as the QA representative for commercial finished goods and external manufacturing partners.
• Manage quality records such as deviations, CAPAs, and change controls.

Skills

Pharmaceutical industry experience

Quality Assurance expertise

Root cause analysis

Continuous improvement initiatives

Education

Bachelor’s degree in life sciences or engineering

Job description

The QA Manager serves as the Quality Assurance representative for commercial finished goods and external manufacturing partners. This role oversees quality activities related to finished goods assembly, labeling, packaging, and serialization to ensure compliance with internal standards and global regulatory requirements. The position partners closely with contract manufacturers and internal stakeholders to support reliable, compliant commercial supply.

Responsibilities

• Act as the QA representative for commercial finished goods and external manufacturing partners.
• Represent Finished Goods Quality Operations at internal meetings and with contract manufacturers supporting commercial production.
• Oversee quality aspects of finished goods specifications, qualification and validation activities, artwork, labeling, serialization, and packaging operations.
• Review and approve manufacturing and labeling documentation, including BOMs, MPRs, product specifications, and variable data.
• Ensure compliant archival of manufacturing partner documentation within the document management system.
• Manage quality records such as deviations, CAPAs, change controls, serialization excursions, and issue escalations related to finished goods operations.
• Identify and recommend continuous improvement initiatives to proactively mitigate risk and support business needs.

Qualifications

• Bachelor’s degree in life sciences, engineering, or a related field.
• Minimum of 5 years of experience within the pharmaceutical or biopharmaceutical industry.
• Hands-on experience with finished goods assembly, labeling, and packaging at external manufacturing sites.
• Experience leading or supporting root cause analysis, investigations, and effective corrective actions.