Senior / Lead Quality Specialist

Meet Life Sciences; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Meet Life Sciences is seeking a Senior Quality Specialist to lead QA activities within a biotech/pharma startup environment. The role supports the QMS, ensures GMP and FDA compliance, and collaborates with Manufacturing, Regulatory, and QC teams.

The ideal candidate has 5+ years in QA/Quality Systems in regulated biotech/pharma settings and strong knowledge of GMP, GxP, and QMS processes. Experience with deviations, CAPAs, and electronic QMS platforms is a plus.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 5+ years of QA/Quality Systems experience in biotech, pharma, or a related regulated industry.
• Strong knowledge of GMP, FDA regulations, GxP, and QMS processes.
• Experience with deviations, CAPAs, change controls, and investigations.
• Strong communication, organizational, and problem-solving skills.
• Experience with electronic QMS platforms such as Veeva, TrackWise, or MasterControl is a plus.

Responsibilities

• Support the QMS, including deviations, CAPAs, change controls, investigations, and document control.
• Review and approve quality documentation, SOPs, and batch records.
• Support GMP compliance, audits, inspections, and quality investigations.
• Partner with Manufacturing, QC, Regulatory, and other cross-functional teams.
• Perform root cause analysis and support continuous improvement initiatives.
• Monitor quality metrics and identify potential compliance or quality risks.

Skills

GMP knowledge

FDA regulations knowledge

QMS processes

Deviations/CAPAs/change controls

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Life Sciences

Tools

Veeva

TrackWise

MasterControl

Job description

Senior Quality Specialist – Biotech/Pharma

I'm working with a growing start up biotech/pharma sponsor client who is looking to grow their team with a senior/lead QA specialist. The ideal candidate will have small/start up experience in the biotech industry.

Job Summary:

The Senior Quality Specialist will support Quality Assurance and the Quality Management System (QMS) within a regulated biotech/pharmaceutical environment. This role will ensure compliance with GMP, FDA regulations, and internal quality standards.

Key Responsibilities:

• Support the QMS, including deviations, CAPAs, change controls, investigations, and document control.
• Review and approve quality documentation, SOPs, and batch records.
• Support GMP compliance, audits, inspections, and quality investigations.
• Partner with Manufacturing, QC, Regulatory, and other cross-functional teams.
• Perform root cause analysis and support continuous improvement initiatives.
• Monitor quality metrics and identify potential compliance or quality risks.

Qualifications:

• Bachelor’s degree in Life Sciences or related field.
• 5+ years of QA/Quality Systems experience in biotech, pharma, or a related regulated industry.
• Strong knowledge of GMP, FDA regulations, GxP, and QMS processes.
• Experience with deviations, CAPAs, change controls, and investigations.
• Strong communication, organizational, and problem-solving skills.
• Experience with electronic QMS platforms such as Veeva, TrackWise, or MasterControl is a plus.