The Quality Engineer, External Quality Operations, will be responsible for ensuring the quality, integrity and compliance of Drug Product manufacturing and packaging operations performed by Contract Manufacturing Organizations.  This role involves close interaction with the SQI Manufacturing team and CMO Quality Assurance counterparts, to ensure robust tech transfer and process validation, and consistent, high-quality manufacturing of SQ Innovation’s commercial products. This is a hybrid position, working from our office located in Burlington, MA.

Responsibilities:

• Oversee Quality aspects of external drug product manufacturing and packaging operations at CMOs to ensure timely and efficient production. 
• May act as the Quality “Person in Plant” at CMOs.
• Work closely with the Supplier Quality group for CMO qualifications, and routine re-qualification.
• Develop and track CMO performance metrics; regularly report to company management.  Work closely with CMO Quality management to address any deficiencies.  Escalate quality issues to senior management.
• Review and approve process validation protocols and reports, deviations/nonconformances, Change Controls, CAPA, etc., specific to SQ Innovation products.
• Provide quality support on MSAT-related projects and continuous improvement initiatives.
• Review CMO Batch Production Records; disposition Drug Product, Medical Devices, and packaged products.
• Draft relevant sections of Annual Product Reviews.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.
• Actively contributes to cross-functional teams, bringing a collaborative and solutions-oriented mindset.
• Additional duties as assigned

Qualifications:

• Bachelor’s degree (preferably in Engineering, Quality management or a related field) or equivalent working experience in the packaging industry.
• Minimum of 7 years of experience in a GMP environment, preferably in sterile injectable drug Quality or manufacturing.  Medical device or drug packaging Quality/manufacturing experience may be acceptable.
• Strong understanding of sterile drug and/or medical device GMPs, regulatory requirements, and quality management systems (QMS).
• Familiarity with packaging processes and regulatory requirements.
• Familiarity with risk management processes for drug and/or device manufacturing.
• Excellent problem-solving skills, attention to detail, and the ability to work individually or collaboratively in a team environment.
• Holds self and others accountable in achieving goals.