Senior Quality Assurance Specialist

SoTalent; United States; Remote; USD 70,000 - 132,000; Full time

Job summary

SoTalent is seeking a Senior Quality Assurance Specialist to ensure compliance with GMP standards in biologics drug substance manufacturing. This remote position involves overseeing quality operations, performing investigations, and maintaining quality agreements while collaborating with various stakeholders. Ideal candidates will possess a strong background in GMP and quality systems related to pharmaceutical manufacturing.

Qualifications

• 5+ years’ experience in GMP manufacturing of biologics drug substance.
• Strong understanding of quality systems and regulatory standards (FDA, EMA).
• Experience working with CMOs or in external manufacturing environments preferred.

Responsibilities

• Oversee quality operations at contract manufacturing sites.
• Perform batch record review, deviation investigations, and lot disposition.
• Conduct audits and contribute to regulatory inspection readiness.

Skills

Communication

Organization

Problem Solving

Education

Bachelor’s degree in pharmacy, chemistry, biotechnology, or related field

Job description

2 days ago Be among the first 25 applicants

Job Title: Senior Quality Assurance Specialist – Drug Substance (Remote)

Overview:

This role supports the quality assurance of biologics drug substance manufacturing, ensuring compliance with GMP standards across contract manufacturers and suppliers. The position sits within the External Manufacturing Quality team and plays a key role in batch review, investigations, audits, and regulatory readiness.

Key Responsibilities:

• Oversee quality operations at contract manufacturing sites
• Perform batch record review, deviation investigations, and lot disposition
• Review and approve change controls, validation documents, and complaints
• Maintain Quality Technical Agreements and support Annual Product Quality Reviews
• Conduct audits and contribute to regulatory inspection readiness
• Collaborate with internal and external stakeholders to resolve quality issues
• Support continuous improvement initiatives and cross-functional projects

Requirements:

• Bachelor’s degree in pharmacy, chemistry, biotechnology, or related field
• 5+ years’ experience in GMP manufacturing of biologics drug substance
• Strong understanding of quality systems and regulatory standards (FDA, EMA, etc.)
• Experience working with CMOs or in external manufacturing environments preferred
• Excellent communication, organization, and problem-solving skills

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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