Pharma: Quality Assurance Manager

HKA Enterprises; Rocky Mount (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

HKA Enterprises in the United States is seeking a Quality Assurance Specialist (Supplier Quality Management) to oversee supplier performance, QA procedures, and regulatory SME support during inspections.

You will perform supplier QA assessments, interpret cGXP for clinical and commercial environments, resolve complex quality issues, and assist with regulatory audits, aiming at continuous process improvements and compliance.

Qualifications

• Bachelor’s degree in Science with 4+ years of experience (or Master’s with 2+ years, PhD with 0, Associate’s with 8, HS Diploma with 10).
• Industry experience in manufacturing, quality, or engineering within biotech/pharma.
• Strong communication, cGXP knowledge, and supplier management expertise.
• Preferred: QA supplier management, quality agreements, and supply chain.

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

cGXP knowledge

Supplier management

Communication

Education

Bachelor’s degree in Science

Master’s degree in related field

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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