Quality Assurance Operations Manager

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced professional to lead and oversee quality assurance operations for late phase and commercial activities, ensuring compliance and continuous improvement within a regulated environment.

Responsibilities:

• Lead and develop quality assurance personnel, providing training and supporting career growth within the department.
• Oversee quality operations including material release, batch record review, lot disposition, and process validation documentation.
• Ensure compliance with cGMP standards and regulatory requirements throughout all operational processes.
• Manage deviation programs, lead investigations, and oversee CAPA and complaint resolution activities.
• Drive continuous improvement initiatives and report on quality system metrics to support operational excellence.
• Collaborate with cross-functional and global teams to implement best practices and align quality systems with regulatory expectations.
• Support and prepare for internal and external audits, including regulatory inspections and customer audits.
• Provide quality oversight for clinical and commercial projects, including technical transfers, stability programs, and risk mitigation.

Qualifications:

• Bachelor’s degree in science or a life science-related field required.
• 7+ years of experience in Quality Assurance within a GMP-regulated environment.
• Minimum of 3 years of management experience, including direct leadership of staff.
• Strong knowledge of FDA, ICH, and EU GxP regulations and guidelines.
• Experience with root cause analysis, CAPA, internal audit systems, and risk management.
• Proven ability to manage major investigations, complaints, and CAPAs.
• Experience with new product development and continuous improvement initiatives.
• Proficiency in Microsoft Office suite and electronic quality management/document control systems.
• Experience in Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) environments preferred.

Published Category: Quality & Validation