Quality Assurance Leader: QMS, Audits & Compliance

HighRes Biosolutions; Beverly (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A biotechnology and automation company in Beverly, Massachusetts seeks a Quality Assurance Manager to ensure compliance with quality standards and lead the Quality Management System. Responsibilities include managing audits, overseeing document control, and enhancing team accountability. Candidates should have a Bachelor's degree and significant experience in the biotech or pharma sector, particularly with regulatory standards.

Qualifications

• 5–10+ years of experience in quality assurance, preferably in biotechnology or pharmaceuticals.
• Strong knowledge of cGMP, GLP, and/or GCP regulations.
• Experience with regulatory inspections and managing audit responses.

Responsibilities

• Develop and manage the Quality Management System (QMS).
• Lead internal and external audits and oversee document control.
• Collaborate with cross-functional teams for quality compliance.

Skills

Quality Assurance

Leadership

Regulatory Compliance

Problem-solving

Communication

Education

Bachelor’s degree in Business, Engineering, Life Sciences

Tools

Quality tools (CAPA, RCA, FMEA, SPC)

Job description

A biotechnology and automation company in Beverly, Massachusetts seeks a Quality Assurance Manager to ensure compliance with quality standards and lead the Quality Management System. Responsibilities include managing audits, overseeing document control, and enhancing team accountability. Candidates should have a Bachelor's degree and significant experience in the biotech or pharma sector, particularly with regulatory standards.