Senior QA Manager, Supplier Quality & Compliance

HKA Enterprises; Cary (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

HKA Enterprises is seeking an experienced QA professional to support supplier quality management for clinical and commercial products. You will drive programs to improve supplier performance, develop QA procedures, and assist regulatory inspections with deep cGXP knowledge.

As an SME in supplier management, you will lead QA activities, perform supplier assessments, quality agreements, and audits, while coaching teammates and coordinating with R&D and other sites.

Qualifications

• Bachelor's degree with 4+ years experience or higher degrees with relevant experience.
• Experience in manufacturing, quality or engineering in biotech/pharma.
• Strong communication and organization skills required.

Responsibilities

• Perform QA assessments and approvals for supplier management.
• Interpret cGXP requirements for clinical and commercial environments.
• Lead or independently resolve complex issues with minimal guidance.
• QA supplier management activities including reassessments, quality agreements, audits, risk assessments.
• QA support and approval for qualification of new suppliers/materials.
• Disposition of incoming materials as applicable.
• Prepare written/oral presentations with minimal input.
• Communicate status and provide performance metrics to team/site management.
• Provide coaching to less experienced colleagues and promote teamwork.
• Participate in external agency audits and train team members.

Skills

Communication skills

Organizational skills

Quality Assurance knowledge

Education

Bachelor's degree in Science or related field

Master's degree in Science or related field

PhD in Science or related field

Associate's degree

High School Diploma with 10 years experience

Job description

HKA Enterprises is seeking an experienced QA professional to support supplier quality management for clinical and commercial products. You will drive programs to improve supplier performance, develop QA procedures, and assist regulatory inspections with deep cGXP knowledge.

As an SME in supplier management, you will lead QA activities, perform supplier assessments, quality agreements, and audits, while coaching teammates and coordinating with R&D and other sites.