Position located in Canton, MA

Responsibilities of the Quality Assurance Manager:

• Will manage quality assurance personnel and ensure appropriate quality systems are in place and that the roles and responsibilities of the quality unit.
• Responsible for ensuring that all products and processes within the company comply with applicable quality standards, regulatory requirements and internal procedures.
• This role will lead the development, implementation, and maintenance of the company’s Quality Management System (QMS).
• Will play a key leadership role in audits, continuous improvement, and fostering a culture of quality across the organization.
• Develop, implement, and manage the Quality Management System (QMS) aligned with applicable regulations.
• Lead internal and external audits (e.g., supplier audits, customer audits/inspections, regulatory inspections, ISO recertification audits, etc.).
• Oversee document control, CAPA, change control, training, and deviation management systems.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality compliance.
• Monitor and report KPIs and trends; provide regular updates to senior management.

Requirements of the Quality Assurance Manager:

• Bachelor’s degree in Business, Engineering, Life Sciences, or related field.
• 5+ years of experience in quality assurance, preferably within the biotechnology and/or pharmaceutical industry.
• Strong knowledge of cGMP, GLP, and/or GCP regulations and applicable quality standards.
• Experience with regulatory inspections and managing audit responses.
• Proficiency with quality tools and methodologies (e.g., CAPA, RCA, FMEA, SPC).
• Proven leadership and team management experience.