Senior QA Lead – cGMP Biotech Quality & Compliance

SAB; Sioux Falls (SD); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking a Senior Quality Assurance Specialist to lead key quality system functions in a biotech environment. With 5+ years of QA experience, you will manage investigations, change control, CAPA, and support regulatory inspections, while mentoring junior staff.

The role requires strong communication, data analysis, and proficiency with eQMS and MS Office. This onsite position offers relocation assistance and opportunities for cross-functional collaboration to uphold product quality and

Qualifications

• 5+ years of quality assurance experience in a regulated manufacturing environment.
• Strong communication skills and ability to present to leadership.
• Experience with quality systems and CAPA/change control.
• Experience with eQMS is highly desirable.
• Proficient in MS Office.

Responsibilities

• Lead and oversee quality oversight of manufacturing and QC operations, including batch record review and deviation investigations.
• Independently lead quality-driven projects and present metrics and validation reviews to leadership.
• Drive ownership of quality systems, including change control, CAPA, and document management.
• Other duties/responsibilities as assigned.

Skills

Quality Assurance

Regulatory Compliance

Communication Skills

Data Analysis

MS Office

Education

BS/BA in life sciences

Tools

eQMS

Job description

SAB BIO is seeking a Senior Quality Assurance Specialist to lead key quality system functions in a biotech environment. With 5+ years of QA experience, you will manage investigations, change control, CAPA, and support regulatory inspections, while mentoring junior staff.

The role requires strong communication, data analysis, and proficiency with eQMS and MS Office. This onsite position offers relocation assistance and opportunities for cross-functional collaboration to uphold product quality and