Senior QA Leader — cGMP Biotech Quality & Compliance

SAB BIO; Sioux Falls (SD); On-site; USD 80,000 - 110,000; 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 and ensure cGMP compliance in a biotech setting. With 4+ years of experience, you will manage investigations, CAPA, change control, and mentor junior QA staff.

The role supports regulatory inspections, cross-functional collaboration, and continuous improvement, with relocation assistance available for onsite work in Sioux Falls.

Qualifications

• BS/BA in life sciences.
• 5+ years of quality assurance experience in a regulated manufacturing environment; pharma or related industry preferred.
• Strong communication skills and proficiency in Microsoft Office.
• Ability to effectively present information in one-on-one, small groups, and company meetings.
• Proficiency in applying mathematical and scientific techniques to compile and analyze data.
• Familiarity with eQMS functionality; experience implementing an eQMS is highly desirable.

Responsibilities

• Lead QA oversight of manufacturing and QC, including batch review, deviation investigations, and cross-functional liaison to ensure compliance with cGMP and internal quality standards.
• Independently lead quality-driven projects and present key quality metrics, training initiatives, and validation documentation reviews to leadership and cross-functional teams.
• Drive ownership of quality systems, including change control, CAPA, and document management, with accountability for process improvement and regulatory alignment.
• Other duties/responsibilities as assigned.

Skills

Quality assurance

Communication

Data analysis

Presentation skills

Continuous improvement

Education

BS/BA in life sciences

Tools

MS Office

eQMS

Job description

SAB BIO is seeking a Senior Quality Assurance Specialist to lead key quality system functions and ensure cGMP compliance in a biotech setting. With 4+ years of experience, you will manage investigations, CAPA, change control, and mentor junior QA staff.

The role supports regulatory inspections, cross-functional collaboration, and continuous improvement, with relocation assistance available for onsite work in Sioux Falls.