Quality Assurance Manager

HKA Enterprises; Rocky Mount (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

HKA Enterprises is seeking a Quality Assurance Specialist (Supplier Quality Management) to support clinical and commercial product compliance by managing supplier performance, maintaining QA procedures, and serving as an SME during regulatory inspections.

You will perform QA assessments for suppliers and incoming materials, interpret cGXP in manufacturing, resolve complex supplier quality issues, and support regulatory audits with metrics while coaching junior teammates.

Qualifications

• Bachelor’s degree in Science plus 4 years of experience, or Master’s + 2 years; PhD + 0 years; Associate’s + 8 years.
• Industry experience in manufacturing, quality, or engineering within biotech/pharma.

Responsibilities

• Perform QA assessments, approvals, and qualifications for suppliers and incoming materials.
• Interpret cGXP for commercial and clinical manufacturing environments.
• Resolve complex supplier quality issues independently and implement process improvements.
• Support regulatory audits, provide performance metrics, and coach junior team members.

Skills

Communication

cGXP knowledge

Supplier management

Education

Bachelor’s degree in Science

Job description

We are hiring a Quality Assurance Specialist (Supplier Quality Management)! This individual contributor role supports clinical and commercial product compliance by managing supplier performance, maintaining QA procedures, and serving as a Subject Matter Expert (SME) during regulatory inspections.

Key Responsibilities:

• Perform QA assessments, approvals, and qualifications for suppliers and incoming materials.
• Interpret cGXPs for commercial and clinical manufacturing environments.
• Resolve complex supplier quality issues independently and implement process improvements.
• Support regulatory audits, provide performance metrics, and coach junior team members.

Qualifications:

Education & Experience: Bachelor’s degree in Science + 4 years of experience (or Master’s + 2 years, PhD + 0 years, Associate’s + 8 years, HS Diploma + 10 years).

Industry Experience: Proven experience in manufacturing, quality, or engineering within the biotech or pharmaceutical industry.

Skills:

Strong communication, cGXP knowledge, and supplier management expertise.

Preferred:

Prior experience with QA supplier management, quality agreements, and supply chain.

Note: Visa sponsorship is not available for this position. Candidates must be currently eligible to work in the U.S. without sponsorship.

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