Remote Corporate Quality & QMS Architect (Part-Time)

The Steely Group; Jersey City (NJ); Hybrid; USD 83,000 - 124,000; Part time

Benefits offered by this job

Remote work

Job summary

The Steely Group is seeking an experienced Corporate Quality Assurance Consultant to oversee and strengthen the company's Quality Management System (QMS), SOP governance, internal audits, and quality training.

This part-time remote engagement focuses on BARDA-related QA activities, Quality Agreements, and alignment with GxP principles, collaborating with CMC QA and functional leaders to build a compliant quality infrastructure.

Qualifications

• Bachelor's degree in life sciences, pharmaceutical sciences, engineering, or related discipline.
• Approximately 10+ years of Quality Assurance experience in pharma/biotech.
• Expertise in developing, administering, and improving QMS.
• Strong knowledge of GxP principles for clinical-stage drug development.
• Experience building SOPs, internal audit programs, training, and QMRs.
• Experience developing and maintaining Quality Agreements with vendors.
• Experience supporting BARDA or government-funded programs preferred.
• Ability to translate quality requirements into pragmatic processes for a small biotech.

Responsibilities

• Oversee the administration, maintenance, and continuous improvement of the company's QMS.
• Lead SOP governance and lifecycle management with functional SMEs.
• Develop and coordinate risk-based internal audit plans and audits.
• Oversee corporate quality training and track completion.
• Coordinate periodic Quality Management Reviews and report trends.
• Establish and maintain Quality Agreements with third-party vendors.
• Provide BARDA quality support, plans, and documentation.

Skills

Quality Assurance

QMS development

GxP knowledge

SOPs & internal audits

Quality training

Regulatory audit readiness

Communication

Independent work

Education

Bachelor's degree in life sciences, pharmaceutical sciences, engineering, or related discipline

Job description

The Steely Group is seeking an experienced Corporate Quality Assurance Consultant to oversee and strengthen the company's Quality Management System (QMS), SOP governance, internal audits, and quality training.

This part-time remote engagement focuses on BARDA-related QA activities, Quality Agreements, and alignment with GxP principles, collaborating with CMC QA and functional leaders to build a compliant quality infrastructure.