Senior QA Lead, Regulated Life Sciences

Bio-techne; Austin (TX); On-site; USD 78,000 - 129,000; Full time

Benefits offered by this job

Medical Insurance

401k with ESPP

Paid time off & Holidays

Job summary

Bio-Techne is seeking a Senior Quality Assurance Specialist to ensure our Quality Management System aligns with global standards. You will collaborate with internal teams to support regulatory compliance and drive product release decisions.

The role involves leading audits, managing CAPAs, NCRs, and training, and guiding QA activities across design and manufacturing. A strong background in regulated facilities is required.

Qualifications

• Bachelor’s degree in a related field; 7–10 years in a regulated facility.
• Master’s degree in a related field; 4–6 years in a regulated facility.
• Strong knowledge of QA principles and related standards (ISO 13485, FDA QMSR).

Responsibilities

• Lead QA compliance with regulatory standards and quality system practices.
• Execute QA production reviews, approvals and product release.
• Lead external audits and summarize results for QA management.
• Manage Training, NCR, CAPA, complaints, internal audits, and supplier quality.
• Lead Quality Management Reviews and risk mitigation plans.

Skills

Microsoft Office

Database management

Attention to detail

Communication skills

Analytical skills

Project leadership

Statistical tools

Education

Bachelor’s degree in a related field

Master’s degree in a related field

Job description

Bio-Techne is seeking a Senior Quality Assurance Specialist to ensure our Quality Management System aligns with global standards. You will collaborate with internal teams to support regulatory compliance and drive product release decisions.

The role involves leading audits, managing CAPAs, NCRs, and training, and guiding QA activities across design and manufacturing. A strong background in regulated facilities is required.